28 jobs found in Morrisville

IQVIA™ is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward. Seeking a Sr. Clinical Research Associate with Oncology/Hematology experience. CAR T experience required BASIC FUNCTIONS: Participates in the preparation and execution of Phase I-IV clinical trials. Oversees the progress of clinical investigations by conducting site evaluation, initiation, and interim close out visits to sites. Monitors clinical trials in accordance with Good Clinical Practices and procedures set forth by IQVIA Biotech and sponsors. Works closely with the Clinical Trial Manager (CTM) and/or Lead CRA t0 ensure all monitoring activities are conducted according to study requirements. The Senior CRA may also serve in the Lead CRA role. ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES: Participates in the investigator recruitment process. Performs site evaluation visits of potential investigators. Evaluates the capability of the site to successfully manage and conduct the clinical study. Collaborates with the ISS department to coordinate activities with the site in preparation for the initiation of the study. Obtains regulatory documentation for successful implementation, monitoring, and evaluation of clinical trials. Works with ISS and site staff to obtain regulatory (IRB/IEC) approval of study specific documents Performs study initiation activities, reviewing with the site personnel the protocol, regulatory issues, study procedures, and provides training on completion of the eCRF; monitoring activities and study close-out activities. Trains site staff on the EDC system and verifies site computer system. Assists in resolving any issues to ensure compliance with site file audits in conjunction with ISS. Assures adherence to Good Clinical Practices, investigator integrity, and compliance with all study procedures through on-site monitoring visits. Performs validation of source documentation as required by sponsor. Prepares monitoring reports and letters per the timelines defined in IQVIA Biotech SOPs by using approved IQVIA Biotech/sponsor templates and reports. Documents accountability, stability and storage conditions of clinical trial materials as required by sponsor. Performs investigational product inventory. Ensures return of unused materials to designated location or verifies destruction as required. Reviews the quality and integrity of the clinical data through (1) in house review of electronic CRF data and (2) on-site source verification. Works with sites to resolve data queries. May review protocols, eCRFs, study manuals and other related documents, as requested by the Clinical Trial Manager and/or Lead CRA. Serves as primary contact between IQVIA Biotech and investigator; coordinates all correspondence; ensures timely transmission of clinical data with the study site and technical reporting, as requested. Performs study close-out visits per the study specific Clinical Monitoring Plan including final investigational product reconciliation and disposition, site study file reconciliation, data query resolution through to database lock and resolution of outstanding action items. Assists with, and attends, Investigator Meetings for assigned studies. Authorized to request site audits due to data integrity concerns. Attends study-related, company, departmental, and external meetings, as required. Ensures internal and study-related trainings are completed per IQVIA Biotech and/or study timelines; CTMS should always be current with the pertinent site updates/contacts. Ensures all study deliverables are completed per IQVIA Biotech and study timelines Conducts Field Evaluation Visits and field training of CRA Is, IIs and other Sr. CRAs. Serves as mentor for junior CRAs and those new to the company and/or study. Performs other duties, as requested. LEAD CRA ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES: The Lead Clinical Research Associate may perform any of the following tasks: Participate in the investigator recruitment process. Perform site evaluation visits, as needed, of potential investigators. Evaluates the capability of the site to successfully manage and conduct the clinical study. Collaborate with the ISS department to coordinate activities with the site in preparation for the initiation of the study. Obtains regulatory documentation for successful implementation, monitoring, and evaluation of clinical trials. Works with ISS and site staff to obtain regulatory (IRB/IEC) approval of study specific documents Perform study initiation activities, reviewing with the site personnel the protocol, regulatory issues, study procedures, and provides training on completion of the eCRF; monitoring activities and study close-out activities. Assists with, and attends, Investigator Meetings for assigned studies. Train site staff on the EDC system and verify site computer system. Assist in resolving any issues to ensure compliance with site file audits in conjunction with ISS. Assure adherence to Good Clinical Practices, investigator integrity, and compliance with all study procedures through on-site monitoring visits. Performs validation of source documentation as required by sponsor. Prepares monitoring reports and letters per the timelines defined in IQVIA Biotech SOPs by using approved IQVIA Biotech/sponsor templates and reports. Document accountability, stability and storage conditions of clinical trial materials as required by sponsor. Performs investigational product inventory. Ensures return of unused materials to designated location or verifies destruction as required. Review the quality and integrity of the clinical data through (1) in house review of electronic CRF data and (2) on-site source verification. Work with sites to resolve data queries. May review draft protocols, eCRFs, monitoring reports and follow-up letters, study manuals and other prepare study-related documents and templates, as requested by the CTM and/or PM. May serve as primary contact between IQVIA Biotech and investigator; coordinates all correspondence; ensures timely transmission of clinical data with the study site and technical reporting, as requested. Assist CTM and/or PM in review of project budgets, monitoring costs, potential overruns and propose/implement cost effective solutions. Assist the study management in identifying and generating changes in scope Perform study close-out visits per the study specific Clinical Monitoring Plan including final investigational product reconciliation and disposition, site study file reconciliation, data query resolution through to database lock and resolution of outstanding action items. Authorized to request site audits due to data integrity concerns. Attends study-related, company, departmental, and external meetings, as required. Ensure internal and study-related trainings are completed per IQVIA Biotech and/or study timelines; CTMS should always be current with the pertinent site updates/contacts. Ensure all study deliverables are completed per IQVIA Biotech and study timelines May conduct Field Evaluation Visits and field training of CRA Is, IIs and Sr CRAs. Serve as mentor for junior CRAs and those new to the company and/or study. Participate in the performance appraisal program by providing timely and accurate feedback regarding the performance of a perspective CRA. Review and approve CRA travel expenses and time sheets. Perform other duties, as requested. TECHNICAL CTM ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES: The Technical CTM may perform any of the following tasks for oncology studies: Create master tracker(s) to house information generated from various reports such as: and CM_Data_Cleaning_Report_By_Subject both Business Objects reports Reconcile patients that have come off treatment and off study Generate and review various IL2 reports Works closely with CDRC to ensure data is further reviewed and discrepancies documented. The Technical CTM may participate in CDRC review and aid in Patient Profile review, as necessary. There may be additional tracking required as a result of CDRC’s review. KNOWLEDGE, SKILLS AND ABILITIES: Strong knowledge of clinical research process, including working knowledge of all functional areas of clinical trials and medical terminology. Four years of oncology experience and/or medical device. Experience in monitoring and/or coordinating clinical trials required. Excellent written and verbal communication skills to express complex ideas to study personnel at research and clinical institutions. Demonstrated ability to form strong functional relationships. Excellent, presentation, organizational and interpersonal skills. Ability to interact with all levels of staff to coordinate/execute study activities. Ability to handle several priorities within multiple, complex trials. Ability to reason independently and recommend specific solutions in clinical settings. Ability to work independently, prioritize, and work within a matrix team environment. Ability to mentor other CRAs and co-monitor, as required. Knowledge of electronic data capture including basic data processing functions. Knowledge of current GCP/ICH guidelines applicable to the conduct of clinical research. Able to qualify for a major credit card, rent an automobile For the Technical CTM role, the CRA must have a deep understanding of IQVIA Biotech systems with the ability to learn even more. PHYSICAL REQUIREMENTS: Very limited physical effort required to perform normal job duties Extensive use of telephone and face-to-face communication requiring accurate perception of speech Extensive use of keyboard requiring repetitive motion of fingers Regular sitting for extended periods of time MINIMUM RECRUITMENT STANDARDS: BS/BA/BSc (or equivalent) in one of the life sciences or health care background (RPh, RN, etc) and a minimum of four (4) years of monitoring/site management experience is required; or equivalent combination of education, training and experience. Prior Clinical Research Organization (CRO) experience preferred. Prior project team leadership experience preferred. Working knowledge of budget management preferred. Must be able to travel domestically and internationally approximately 65%-85%. Valid driver’s license Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer CLASSIFICATION (US): This position is classified as exempt under the Fair Labor Standards Act; employees are not eligible for overtime compensation. Join Us Making a positive impact on human health takes insight, curiosity, and intellectual courage. It takes brave minds, pushing the boundaries to transform healthcare. Regardless of your role, you will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve outcomes for patients. Forge a career with greater purpose, make an impact, and never stop learning. IQVIA is an EEO Employer - Minorities/Females/Protected Veterans/Disabled IQVIA, Inc. provides reasonable accommodations for applicants with disabilities. Applicants who require reasonable accommodation to submit an application for employment or otherwise participate in the application process should contact IQVIA’s Talent Acquisition team at [Click Here to Email Your Resumé] to arrange for such an accommodation. Job ID: R1109789

As a member of the Information Systems team, the position of Senior Programming Analyst will have technical responsibility for the enhancement and support of applications systems. In this position the candidate will review, analyze, and modify programming systems to support business requirements. Analysis of administrative application system, technical design and extremely strong applications programming skills are necessary to properly support Crown's corporate headquarters administrative applications. The primary role will be to support Crown's Infinium applications and support systems. The coverage of responsibility includes United States business divisions, our Canadian operations, and our Mexican operations. The information systems support function for the Administrative and financial applications are centralized at the corporate headquarters located in Yardley, PA. Reporting Relationships The Senior Programming Analyst will report to the Manager Infinium Systems, who reports to the Director Administrative Systems who in turn reports to the V.P. Information Services. The incumbent will assume a leadership role within their respective applications support group. This position is located at Crown's corporate headquarters in Yardley. Functional Responsibilities ?Provide hands-on system technical support to the Crown Infinium Applications and support systems. ?Provide quality, effective and consistent computing solutions to all of our facilities as may be required. Included are training issues, phone requests and problem resolution. ?Assume the role of lead programming analyst on projects and implementation of enhancements to the environment. ?May lead and direct the work of others on the programming staff. A minimum of 5 years experience in systems support function. A keen understanding of the Infinium environment and application system & program code is preferred. A superior in depth knowledge and experience with iSeries systems, RPG400 and ILE is a must. Will be expected to perform a variety of complicated analysis and programming tasks. Experience with software tools required for change control and impact analysis: SoftLanding's Turnover and Pathfinders Hawkeye. Experienced in systems development, design, implementation and post-implementation processes. Strong database experience covering design, creation and utilization is essential. Excellent oral and written communication skills plus the ability to successfully interact with all levels of management.

Join us on our exciting journey IQVIA™ is The Human Data Science Company™, focused on using data and science to help healthcare clients find better solutions for their patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness advances in healthcare information, technology, analytics and human ingenuity to drive healthcare forward. The medical department consists of a Chief Medical Officer, Medical Directors, medical writers, and safety associates. The Senior Medical Director provides medical and scientific support to clinical research programs, study teams and investigators. The Senior Medical Director also provides review, advice, and leadership for potentially or actually awarded clinical research programs. The Senior Medical Director role is a team member participant role and functions in a matrix report to project teams much like other members of the project teams. The primary role of Senior Medical Director is to provide medical oversight for clinical trials by serving as Medical Monitor for studies conducted by IQVIA Biotech Clinical on behalf of sponsor companies. The principal function of a Medical Monitor is to serve as primary contact for the sponsor medical team and to serve as front line medical resource to support the project team. The Medical Monitor is customarily available 24/7 to answer questions from site coordinators and investigators on protocol inclusion/exclusion criteria, protocol clarifications, and compliance issues, and to provide review of alert labs per sponsor preference. Major duties of the Medical Director are outlined below: ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES: Functions as project team member Provides medical and scientific input to clinical research programs including review of new business proposals, preclinical and/or clinical data, study protocols, training materials, informed consent, Investigator Drug Brochures, eCRFs, analysis plan designs, clinical study reports, regulatory approval submissions, serious and non-serious adverse event evaluation and reporting Ensures medical activities run according to GCP and operate with highest efficiency Establishes and maintains a network of medical/scientific consultants, etc. Supervises and manages Medical Director activities Clinical Activities: Interacts with clients regarding drug development programs, study design and protocol Reviews and provides input for protocol development. Interacts with key thought leaders and/or sponsor representatives to develop inclusion/exclusion criteria and study endpoints. Interacts in team approach to develop statistical and data management sections of the protocol. Reviews the final protocol for clinical, safety and efficacy variables. Provides project team training on protocol and/or therapeutic areas Assists team with developing criteria for investigator site selection and networking for potential investigators for study participation. Aids in review and final selection. Participates in subject recruitment and retention activities including individual calls to key opinion leaders, investigators and site staff and/or participation in teleconference and WebEx presentations Presents protocol and/or safety reporting information at investigator meetings Develops project medical monitoring plans as requested Provides on call coverage for protocol queries and site support. Provides first line contact for investigators and monitors regarding study related medical/safety issues and resolution of study protocol and patient eligibility issues. Safety Monitoring and SAE Reporting Activities: Verifies the medical accuracy of patient safety data and maintains an ongoing assessment of the safety profile of the study Provides medical review of SAE reporting, writes and/or reviews SAE narratives, and works with the Safety Management Department to track SAEs and follow-up on outstanding safety queries, interacts with sponsor and discusses safety issues with site as needed Reviews IND/SUSAR Safety Reports (per sponsor preference), updates to Investigator Brochures, and annual IND reports with sponsor data In consultation with the sponsor, follow procedures for acquiring knowledge of subject treatment assignments (i.e. breaking the blind) Interact with appropriate FDA officials concerning safety and other study related issues, as requested Data Activities: Provides medical review of eCRFs for clinical accuracy Provides medical review of data analysis plan Reviews safety fields at case freeze for reconciliation (if needed) Works with data group to reconcile SAE events as needed Reviews medical coding of adverse events, laboratory data and concomitant medications for accuracy, coherence, consistency, and trends Reviews data tables, listings, and figures Reviews and/or writes portions of final clinical study report DSMB/Adjudication Committee Activities: May assist sponsor in choosing committee members May serve as a non-voting member to convene and organize proceedings May develop operating guidelines in conjunction with committee members and submits these to sponsor for review May determine data flow with sponsor to ensure reporting accuracy Can ensure DSMB feedback is given to sites for IRBs All DSMB activities are usually managed by the IQVIA Biotech Oversight Management Group and not the IQVIA Biotech medical monitor Business Development Activities Work with Business Development to actively solicit new business for Novella Clinical, including assistance with marketing presentations and proposal development Supports business development activities with proposal development and sales presentations Participates in feasibility discussions relating to specific project proposals Special Projects: Obtain literature searches to acquire background information for study proposals, preparation of training sessions, and interpretation of clinical data, report writing, etc. Assists with drafting of standard operating procedures and working practices regarding all Medical Director activities Participate in a variety of team quality improvement efforts as necessary Perform other related duties as assigned or requested by the Chief Medical Officer KNOWLEDGE, SKILLS, AND ABILITIES: Ability to work in partnership with a multidisciplinary group of colleagues, including translating concepts into practical approaches and promoting consensus Outstanding ability to work independently with minimal supervision, ability to work effectively within a team, and matrix environment Ability to organize and work efficiently on several projects, each with specific requirements and/or shifting priorities Excellent oral and written communications skills as well as interpersonal skills are essential Oncology; Hematology; CRITICAL JOB FUNCTIONS IN ACCORDANCE WITH ADA CRITERIA: Ability to travel domestically and internationally as required Very limited physical effort required to perform normal job duties MINIMUM RECRUITMENT STANDARDS: Current or prior license to practice medicine; board certification/eligibility ideal Minimum 3-5 years of biopharmaceutical industry experience or academic experience in clinical research and drug development Board Certified / Board Eligible: Oncology/ Hematology IQVIA is an EEO Employer - Minorities/Females/Protected Veterans/Disabled' We know that meaningful results require not only the right approach but also the right people. Regardless of your role, we invite you to reimagine healthcare with us. You will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve human health outcomes. Whatever your career goals, we are here to ensure you get there We invite you to join IQVIA™ Job ID: R1058532

Who is Cenlar? You are. Employee-owners have made Cenlar one of the nation’s largest mortgage subservicers. We have achieved success by empowering people with company ownership, real programs that provide avenues for advancement, and a great atmosphere that makes everyone look forward to the workday. Get your share of our success by considering the opportunity to join our team as a Sr. QA Analyst. Job Summary: Responsible for conducting activities that ensure that application/system products and projects meet defined quality standards. Activities include: developing, conducting and evaluating application audits and testing processes; leading and/or conducting testing activities; and communicating with developers to correct system bugs. Incumbents in this area typically have in-depth knowledge of automated testing tools, quality control and quality assurance approaches. Responsibilities: Provide structured approach to test planning and execution for validation of daily data extracts and reports that support critical business functions for Cenlar clients. Be able to create test architecture and test strategy early enough to drive software development and testing approach. This practice should be able to morph into Agile and Test Driven Development. Document QA and Test Procedures and recommend updates to QA processes. Ensure that QA procedures and processes are followed across all QA activities BAU or Projects. Develop and maintain Regression Test Strategy to ensure frequent production changes are properly tested Participate in business and functional requirements and technical design reviews to develop understanding of testing requirements, create test plans and schedules Provide management level updates on QA Testing, Defects and Risks including key Metrics Work very close as a part of the agile team and develop a strong understanding of the project and testing objectives Participate in troubleshooting and triaging of issues with different teams to drive towards root cause identification and resolution Document, track and escalate issues as appropriate, using Jira and other such tools Support testing and/or application deployment during the off-hours for “validation testing” Perform risk based testing when appropriate Work on multiple projects at the same time and be able to meet project milestones Qualifications: 10 years of hands-on testing experience (mortgage/financial industry a plus) 4 years of experience with developing automation framework and automation tools including but not limited to Java, Selenium Web Driver, QTP/UFT, TestNG, Junit, or similar tools Typically requires an individual emerging as an expert in a specific skill set, business area or product but who remain focused primarily on daily execution. Primary focus of role is on day-to-day deliverables, developing solutions based upon subject expertise, and occasionally representing the department at a broader level. Typically minimum of 5 years of experience. Total Rewards : Cenlar FSB offers outstanding benefits which may include paid medical/dental/life insurance, 401k, employee ownership, tuition assistance, a supportive work environment, and genuine opportunities for advancement. Cenlar is a Drug Free Workplace and an Equal Employment Opportunity/Affirmative Action Employer M/F/D/V/SO. Visit www.cenlar.com for more details. Please apply online .

IQVIA™ is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward. BASIC FUNCTIONS: Participates in the preparation and execution of Phase I-IV clinical trials. Oversees the progress of clinical investigations by conducting site evaluation, initiation, and interim close out visits to sites. Monitors clinical trials in accordance with Good Clinical Practices and procedures set forth by IQVIA Biotech and sponsors. Works closely with the Clinical Trial Manager (CTM) and/or Lead CRA t0 ensure all monitoring activities are conducted according to study requirements. The Senior CRA may also serve in the Lead CRA role. ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES: Participates in the investigator recruitment process. Performs site evaluation visits of potential investigators. Evaluates the capability of the site to successfully manage and conduct the clinical study. Collaborates with the ISS department to coordinate activities with the site in preparation for the initiation of the study. Obtains regulatory documentation for successful implementation, monitoring, and evaluation of clinical trials. Works with ISS and site staff to obtain regulatory (IRB/IEC) approval of study specific documents Performs study initiation activities, reviewing with the site personnel the protocol, regulatory issues, study procedures, and provides training on completion of the eCRF; monitoring activities and study close-out activities. Trains site staff on the EDC system and verifies site computer system. Assists in resolving any issues to ensure compliance with site file audits in conjunction with ISS. Assures adherence to Good Clinical Practices, investigator integrity, and compliance with all study procedures through on-site monitoring visits. Performs validation of source documentation as required by sponsor. Prepares monitoring reports and letters per the timelines defined in IQVIA Biotech SOPs by using approved IQVIA Biotech/sponsor templates and reports. Documents accountability, stability and storage conditions of clinical trial materials as required by sponsor. Performs investigational product inventory. Ensures return of unused materials to designated location or verifies destruction as required. Reviews the quality and integrity of the clinical data through (1) in house review of electronic CRF data and (2) on-site source verification. Works with sites to resolve data queries. May review protocols, eCRFs, study manuals and other related documents, as requested by the Clinical Trial Manager and/or Lead CRA. Serves as primary contact between IQVIA Biotech and investigator; coordinates all correspondence; ensures timely transmission of clinical data with the study site and technical reporting, as requested. Performs study close-out visits per the study specific Clinical Monitoring Plan including final investigational product reconciliation and disposition, site study file reconciliation, data query resolution through to database lock and resolution of outstanding action items. Assists with, and attends, Investigator Meetings for assigned studies. Authorized to request site audits due to data integrity concerns. Attends study-related, company, departmental, and external meetings, as required. Ensures internal and study-related trainings are completed per IQVIA Biotech and/or study timelines; CTMS should always be current with the pertinent site updates/contacts. Ensures all study deliverables are completed per IQVIA Biotech and study timelines Conducts Field Evaluation Visits and field training of CRA Is, IIs and other Sr. CRAs. Serves as mentor for junior CRAs and those new to the company and/or study. Performs other duties, as requested. LEAD CRA ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES: The Lead Clinical Research Associate may perform any of the following tasks: Participate in the investigator recruitment process. Perform site evaluation visits, as needed, of potential investigators. Evaluates the capability of the site to successfully manage and conduct the clinical study. Collaborate with the ISS department to coordinate activities with the site in preparation for the initiation of the study. Obtains regulatory documentation for successful implementation, monitoring, and evaluation of clinical trials. Works with ISS and site staff to obtain regulatory (IRB/IEC) approval of study specific documents Perform study initiation activities, reviewing with the site personnel the protocol, regulatory issues, study procedures, and provides training on completion of the eCRF; monitoring activities and study close-out activities. Assists with, and attends, Investigator Meetings for assigned studies. Train site staff on the EDC system and verify site computer system. Assist in resolving any issues to ensure compliance with site file audits in conjunction with ISS. Assure adherence to Good Clinical Practices, investigator integrity, and compliance with all study procedures through on-site monitoring visits. Performs validation of source documentation as required by sponsor. Prepares monitoring reports and letters per the timelines defined in IQVIA Biotech SOPs by using approved IQVIA Biotech/sponsor templates and reports. Document accountability, stability and storage conditions of clinical trial materials as required by sponsor. Performs investigational product inventory. Ensures return of unused materials to designated location or verifies destruction as required. Review the quality and integrity of the clinical data through (1) in house review of electronic CRF data and (2) on-site source verification. Work with sites to resolve data queries. May review draft protocols, eCRFs, monitoring reports and follow-up letters, study manuals and other prepare study-related documents and templates, as requested by the CTM and/or PM. May serve as primary contact between IQVIA Biotech and investigator; coordinates all correspondence; ensures timely transmission of clinical data with the study site and technical reporting, as requested. Assist CTM and/or PM in review of project budgets, monitoring costs, potential overruns and propose/implement cost effective solutions. Assist the study management in identifying and generating changes in scope Perform study close-out visits per the study specific Clinical Monitoring Plan including final investigational product reconciliation and disposition, site study file reconciliation, data query resolution through to database lock and resolution of outstanding action items. Authorized to request site audits due to data integrity concerns. Attends study-related, company, departmental, and external meetings, as required. Ensure internal and study-related trainings are completed per IQVIA Biotech and/or study timelines; CTMS should always be current with the pertinent site updates/contacts. Ensure all study deliverables are completed per IQVIA Biotech and study timelines May conduct Field Evaluation Visits and field training of CRA Is, IIs and Sr CRAs. Serve as mentor for junior CRAs and those new to the company and/or study. Participate in the performance appraisal program by providing timely and accurate feedback regarding the performance of a perspective CRA. Review and approve CRA travel expenses and time sheets. Perform other duties, as requested. TECHNICAL CTM ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES: The Technical CTM may perform any of the following tasks for oncology studies: Create master tracker(s) to house information generated from various reports such as: and CM_Data_Cleaning_Report_By_Subject both Business Objects reports Reconcile patients that have come off treatment and off study Generate and review various IL2 reports Works closely with CDRC to ensure data is further reviewed and discrepancies documented. The Technical CTM may participate in CDRC review and aid in Patient Profile review, as necessary. There may be additional tracking required as a result of CDRC’s review. KNOWLEDGE, SKILLS AND ABILITIES: Strong knowledge of clinical research process, including working knowledge of all functional areas of clinical trials and medical terminology. Four years of oncology experience and/or medical device. Experience in monitoring and/or coordinating clinical trials required. Excellent written and verbal communication skills to express complex ideas to study personnel at research and clinical institutions. Demonstrated ability to form strong functional relationships. Excellent, presentation, organizational and interpersonal skills. Ability to interact with all levels of staff to coordinate/execute study activities. Ability to handle several priorities within multiple, complex trials. Ability to reason independently and recommend specific solutions in clinical settings. Ability to work independently, prioritize, and work within a matrix team environment. Ability to mentor other CRAs and co-monitor, as required. Knowledge of electronic data capture including basic data processing functions. Knowledge of current GCP/ICH guidelines applicable to the conduct of clinical research. Able to qualify for a major credit card, rent an automobile For the Technical CTM role, the CRA must have a deep understanding of IQVIA Biotech systems with the ability to learn even more. PHYSICAL REQUIREMENTS: Very limited physical effort required to perform normal job duties Extensive use of telephone and face-to-face communication requiring accurate perception of speech Extensive use of keyboard requiring repetitive motion of fingers Regular sitting for extended periods of time MINIMUM RECRUITMENT STANDARDS: BS/BA/BSc (or equivalent) in one of the life sciences or health care background (RPh, RN, etc) and a minimum of four (4) years of monitoring/site management experience is required; or equivalent combination of education, training and experience. Prior Clinical Research Organization (CRO) experience preferred. Prior project team leadership experience preferred. Working knowledge of budget management preferred. Must be able to travel domestically and internationally approximately 65%-85%. Valid driver’s license Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer CLASSIFICATION (US): This position is classified as exempt under the Fair Labor Standards Act; employees are not eligible for overtime compensation. Join Us Making a positive impact on human health takes insight, curiosity, and intellectual courage. It takes brave minds, pushing the boundaries to transform healthcare. Regardless of your role, you will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve outcomes for patients. Forge a career with greater purpose, make an impact, and never stop learning. IQVIA is an EEO Employer - Minorities/Females/Protected Veterans/Disabled IQVIA, Inc. provides reasonable accommodations for applicants with disabilities. Applicants who require reasonable accommodation to submit an application for employment or otherwise participate in the application process should contact IQVIA’s Talent Acquisition team at [Click Here to Email Your Resumé] to arrange for such an accommodation. Job ID: R1112643

Business Analyst Pay 35 Location Morrisville Duration 6-20 Business Analyst to manage the processes for deploying and analyzing a global survey across multiple geographies. As part of the work duties, the Business Analyst must interact with stakeholders across multiple geographies to collect contact data for customers who should receive the survey, and then convert this contact data to a consistent format in Excel files to load into the survey platform. This process will require superior communication and collaboration skills. The individual will need to be able to balance the different needs of each stakeholder in reporting the results of the survey. The format for the reporting is already established, so the Business Analyst will need to follow existing processes to analyze the data in Excel and then present it in existing PowerPoint presentation formats. The individual will also need to work with the existing team performing these responsibilities to transition this work to the Business Analyst role. This will include documenting the existing processes clearly to ensure there is a strong record of how to replicate the work for deploying and analyzing the survey in the future. In addition, the Business Analyst will be expected to identify opportunities to automate or simplify existing manual processes, as well as clearly identify any key differences in requirements across the different geographies. • Intermediate skills in Microsoft Office, with a strong focus on Excel • Intermediate skills in process documentation and optimization • Leading projects across multiple organizations with competing priorities and requirements • Excellent written and verbal communication skills • Great analytical, critical thinking and problem-solving abilities • Strong project management and organizational skills • Adaptable and capable of working in fast-paced environments • Minimum 2 years of Business Analyst experience • Bachelor's degree or higher in business analysis, business administration, finance or related field Experience in a multinational corporation • Experience with managing the creation, deployment and analysis of surveys, particularly with B2B clients

Recognition: Inc. 500 & 5000 Honoree Company for 2012 , 2013, 2014 ,2015 and 2016 Atyeti Ranks No. 270 on the 2012 Inc. 500 List 2012 & 2016 NJ 50 Fastest Growing Companies Leading Investment Bank in Morrisville, NC area is looking for a Sr Full Stack Java Developer. (Long Term Contract) Please email me your updated resumes with rate expectations to sangitha.ganesh(at)atyeti.com / Call - 919 583 2695 Job Overview The team will be part of a globally distributed organization responsible for developing and supporting its Data Management platform and will report directly to management based in New York. Take business requirements and develop solutions front to back in Core Java//Html5/Oracle, making changes in all application tiers writing robust testable code. Work in a small agile team. Gain experience working in large, complex, high volume multi-node distributed systems. Have practical experience of Continuous Integration / Deployment pipelines using Jenkins / Teamcity or similar. Be willing and able to adapt to changes in priorities and requirements. Provide L3 support of the application in the US time zone including interacting with business users and L2 support staff. Work on challenging technical problems involving availability, scalability, performance, data provenance, and large quantities of data. Identify and investigate performance issues in the Java middle tier layer using amongst others Mission Control, Eclipse Memory Analyzer or similar Identify and investigate performance issues in the DB layer using amongst others query plans, AWR reports or similar. You offer You hold a Degree in Computer Science or related technical discipline (preferred but not required) A consistent track record of developing enterprise, multi-tier applications in Java 8 or above. Expertise in Server side tools and technologies like Core Java, JEE, Spring Boot, Spring Integration, Apache CXF including build tools like Maven/Gradle Strong knowledge on web technologies Angular, HTML5, JavaScript and working experience on web servers Jetty/Tomcat. Good knowledge of distributed in memory caching technologies Good understanding of messaging (JMS) and Enterprise Messaging technologies. Strong knowledge on Restful/SOAP web services Good knowledge of an RDBMS preferably Oracle. Strong (PL)SQL skills including performance tuning and optimization. Sound knowledge and experience of Unix/Linux commands Good understanding of DevOps principles and practices with focus on Continuous Integration and Continuous Development using tool chains such as SVN/ /Jenkins/TeamCity/Crucible/Sonar Expertise with JUnit, Mockito, TestNG or any other test framework - provided by Dice

IQVIA™ is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward. IQVIA Biotech - Candidates can be Office or Home based anywhere in the US. BASIC FUNCTIONS: Provide statistical consulting and technical support as it relates to the design and statistical analysis of clinical studies. Determine analysis and data presentation specifications for SAS Programming staff. Perform analysis, interpret study results, and collaborate with medical and biostatistics staff to produce interim reports and final reports. May be responsible for more than one study. ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES: Collaborates with program staff on the implementation and analysis of statistical aspects of research protocols. Assists Senior Statistician in providing statistical consultation for clinical programs, including but not limited to randomization, sample size assessments, efficacy evaluations, and data review. Interfaces with clients as the project biostatistician. Provides input to project timelines, and ensures that project timelines for biostatistics deliverables are met for both internal and external clients. Ensures that project tasks are completed with acceptable quality for both internal and external clients. Coordinates with SAS programming staff to ensure the accurate programming of SAS clinical data extracts and data displays. Develops statistical analysis summary and analysis plans, including textual description of planned analysis and mock-ups of data displays. Reviews and provides comments on statistical summaries. Develops programming specifications to summarize the results of clinical trials, including analysis datasets and tables/listings/figures. Performs statistical analyses, including hypothesis testing and modeling. Provides tabular and written summaries of analyses and statistical methodology for Clinical Study Reports. Interacts with Medical Writers to ensure appropriateness of data inferences. Writes pertinent sections of a clinical study report. Attends team meetings and represents departmental needs for assigned projects. KNOWLEDGE, SKILLS AND ABILITIES: Ability to synthesize results in graphic, oral, and written reports. Understanding of GCP, ICH, and FDA guidelines and regulations applicable to conduct clinical research. Experience with statistical methods commonly used in the analysis of clinical trial data. Experience with SAS Base and SAS Stat, as well as strong data step skills. Experience with other statistical software packages, such as N-Query, S-Plus. Ability to work creatively and independently to carry out assignments of a complex nature. Ability to work effectively and cooperatively with other professional staff members. Ability to communicate effectively, both verbally and in writing, with all levels of staff and with the public. CRITICAL JOB FUNCTIONS IN ACCORDANCE WITH ADA CRITERIA: Very limited physical effort required to perform normal job duties. MINIMUM RECRUITMENT STANDARDS: Degree requirements include one of the following: Masters-level degree in Statistics, Biostatistics or related field with two years relevant work experience; total work experience to include one year in CRO industry or biotech; or Doctorate-level degree in Statistics, Biostatistics or related field with one year relevant work experience in CRO industry or biotech. Data handling and analysis experience. Excellent interpersonal and organization skills. Join Us Making a positive impact on human health takes insight, curiosity, and intellectual courage. It takes brave minds, pushing the boundaries to transform healthcare. Regardless of your role, you will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve outcomes for patients. Forge a career with greater purpose, make an impact, and never stop learning. IQVIA is an EEO Employer - Minorities/Females/Protected Veterans/Disabled IQVIA, Inc. provides reasonable accommodations for applicants with disabilities. Applicants who require reasonable accommodation to submit an application for employment or otherwise participate in the application process should contact IQVIA’s Talent Acquisition team at [Click Here to Email Your Resumé] to arrange for such an accommodation. Job ID: R1108463

IQVIA™ is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward. • Serves as the primary contact with the project team and Sponsor across multiple projects. • Provides project forecasts of investigator payments at agreed upon intervals for the projects. • Maintain adequate cash balances for projects; communicate with the study PM and the Sponsor for inquiries related to the invoice status. • Provide study PM with detailed payment tracker, as needed, to accompany billing to Sponsor. • Assist study PM with communication to Sponsor regarding financial needs of project for investigator payments. • Oversee budget file creation and accountable for the quality and accuracy of the file. • Works with the Investigator Payment Specialist/Assistant to troubleshoot any issues arising on the project. • Reviews and analyzes the patient payment reports in preparation for paying sites; troubleshoots any issues with the programming team. • May support the financial forecasting for their projects. • Verify/Ensure all payments to sites on the site payment tracker have been updated by the Investigator Payment Specialist. • Ensures the site payment tracker is reconciled monthly and matches the information in the accounting system. • Responsible for the processing of all site invoices for payments and obtaining all required sponsor and PM approvals; review site invoices against site contracts to make sure payment amount and details of the invoice match the site’s fully executed contracts. • Review Site’s fully executed contract so key payment information for each site can be documented. • Work with IQVIA Biotech’s technical departments and Investigator Payments Programming Lead to review specifications for site payment reports to ensure all appropriate data and criteria are captured within the report programming. • Communicates directly and liaises with technical departments/Investigator Payments Programming Lead on changes to projects that affect site payment report programming. • Maintains schedule for patient visit payments per contract with the Sponsor and the Site. Ensures all site payments for patient visits are processed. Review the site payment report based on the required due date for payments to be made to make sure the report is correct and free of errors before processing any payments. • Review calculation of manual patient visits payments prepared by Investigator Payment Specialist. • Verifies all required tax documents and completed required vendor forms are received and submitted to parent company for processing in accounting system by the Investigator Payment Specialist • Review site contracts templates, when requested, by the Site Contracts department to verify the information requested by the site will not cause any future payment issues. • Assist management with oversight of the day to day training and mentoring of new staff, as needed. • Maintain Company Outlook folders with all correspondence related to assigned studies. • Maintain filing of all payment backup for all assigned studies. • Assist Company with all Physician Financial Transparency Reporting for all assigned projects, as needed. • Attend Sponsor calls when required. • Performs other duties as assigned. Join Us Making a positive impact on human health takes insight, curiosity, and intellectual courage. It takes brave minds, pushing the boundaries to transform healthcare. Regardless of your role, you will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve outcomes for patients. Forge a career with greater purpose, make an impact, and never stop learning. IQVIA is an EEO Employer - Minorities/Females/Protected Veterans/Disabled IQVIA, Inc. provides reasonable accommodations for applicants with disabilities. Applicants who require reasonable accommodation to submit an application for employment or otherwise participate in the application process should contact IQVIA’s Talent Acquisition team at [Click Here to Email Your Resumé] to arrange for such an accommodation. Job ID: R1105615

Join us on our exciting journey IQVIA™ is The Human Data Science Company™, focused on using data and science to help healthcare clients find better solutions for their patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness advances in healthcare information, technology, analytics and human ingenuity to drive healthcare forward. The medical department consists of a Chief Medical Officer, Medical Directors, medical writers, and safety associates. The Senior Medical Director provides medical and scientific support to clinical research programs, study teams and investigators. The Senior Medical Director also provides review, advice, and leadership for potentially or actually awarded clinical research programs. The Senior Medical Director role is a team member participant role and functions in a matrix report to project teams much like other members of the project teams. The primary role of Senior Medical Director is to provide medical oversight for clinical trials by serving as Medical Monitor for studies conducted by Novella Clinical on behalf of sponsor companies. The principal function of a Medical Monitor is to serve as primary contact for the sponsor medical team and to serve as front line medical resource to support the project team. The Medical Monitor is customarily available 24/7 to answer questions from site coordinators and investigators on protocol inclusion/exclusion criteria, protocol clarifications, and compliance issues, and to provide review of alert labs per sponsor preference. Major duties of the Medical Director are outlined below: ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES: Functions as project team member Provides medical and scientific input to clinical research programs including review of new business proposals, preclinical and/or clinical data, study protocols, training materials, informed consent, Investigator Drug Brochures, eCRFs, analysis plan designs, clinical study reports, regulatory approval submissions, serious and non-serious adverse event evaluation and reporting Ensures medical activities run according to GCP and operate with highest efficiency Establishes and maintains a network of medical/scientific consultants, etc. Supervises and manages Medical Director activities Clinical Activities: Interacts with clients regarding drug development programs, study design and protocol Reviews and provides input for protocol development. Interacts with key thought leaders and/or sponsor representatives to develop inclusion/exclusion criteria and study endpoints. Interacts in team approach to develop statistical and data management sections of the protocol. Reviews the final protocol for clinical, safety and efficacy variables. Provides project team training on protocol and/or therapeutic areas Assists team with developing criteria for investigator site selection and networking for potential investigators for study participation. Aids in review and final selection. Participates in subject recruitment and retention activities including individual calls to key opinion leaders, investigators and site staff and/or participation in teleconference and WebEx presentations Presents protocol and/or safety reporting information at investigator meetings Develops project medical monitoring plans as requested Provides on call coverage for protocol queries and site support. Provides first line contact for investigators and monitors regarding study related medical/safety issues and resolution of study protocol and patient eligibility issues. Safety Monitoring and SAE Reporting Activities: Verifies the medical accuracy of patient safety data and maintains an ongoing assessment of the safety profile of the study Provides medical review of SAE reporting, writes and/or reviews SAE narratives, and works with the Safety Management Department to track SAEs and follow-up on outstanding safety queries, interacts with sponsor and discusses safety issues with site as needed Reviews IND/SUSAR Safety Reports (per sponsor preference), updates to Investigator Brochures, and annual IND reports with sponsor data In consultation with the sponsor, follow procedures for acquiring knowledge of subject treatment assignments (i.e. breaking the blind) Interact with appropriate FDA officials concerning safety and other study related issues, as requested Data Activities: Provides medical review of eCRFs for clinical accuracy Provides medical review of data analysis plan Reviews safety fields at case freeze for reconciliation (if needed) Works with data group to reconcile SAE events as needed Reviews medical coding of adverse events, laboratory data and concomitant medications for accuracy, coherence, consistency, and trends Reviews data tables, listings, and figures Reviews and/or writes portions of final clinical study report DSMB/Adjudication Committee Activities: May assist sponsor in choosing committee members May serve as a non-voting member to convene and organize proceedings May develop operating guidelines in conjunction with committee members and submits these to sponsor for review May determine data flow with sponsor to ensure reporting accuracy Can ensure DSMB feedback is given to sites for IRBs All DSMB activities are usually managed by the Novella Oversight Management Group and not the Novella medical monitor Business Development Activities Work with Business Development to actively solicit new business for Novella Clinical, including assistance with marketing presentations and proposal development Supports business development activities with proposal development and sales presentations Participates in feasibility discussions relating to specific project proposals Special Projects: Obtain literature searches to acquire background information for study proposals, preparation of training sessions, and interpretation of clinical data, report writing, etc. Assists with drafting of standard operating procedures and working practices regarding all Medical Director activities Participate in a variety of team quality improvement efforts as necessary Perform other related duties as assigned or requested by the Chief Medical Officer KNOWLEDGE, SKILLS, AND ABILITIES: Ability to work in partnership with a multidisciplinary group of colleagues, including translating concepts into practical approaches and promoting consensus Outstanding ability to work independently with minimal supervision, ability to work effectively within a team, and matrix environment Ability to organize and work efficiently on several projects, each with specific requirements and/or shifting priorities Excellent oral and written communications skills as well as interpersonal skills are essential CRITICAL JOB FUNCTIONS IN ACCORDANCE WITH ADA CRITERIA: Ability to travel domestically and internationally as required Very limited physical effort required to perform normal job duties MINIMUM RECRUITMENT STANDARDS: Current or prior license to practice medicine; Minimum 3-5 years of biopharmaceutical industry experience or academic experience in clinical research and drug development U. S. Board Certified/Eligible – Dermatology preferred We know that meaningful results require not only the right approach but also the right people. Regardless of your role, we invite you to reimagine healthcare with us. You will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve human health outcomes. Whatever your career goals, we are here to ensure you get there We invite you to join IQVIA™ IQVIA is an EEO Employer - Minorities/Females/Protected Veterans/Disabled IQVIA, Inc. provides reasonable accommodations for applicants with disabilities. Applicants who require reasonable accommodation to submit an application for employment or otherwise participate in the application process should contact IQVIA’s Talent Acquisition team at [Click Here to Email Your Resumé] to arrange for such an accommodation. Job ID: R1075268

IQVIA™ is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward. Responsible for the successful planning, implementation and execution of contracted clinical monitoring activities CAR T cell therapy studies. Functionally responsible for all clinical monitoring team members throughout the duration of each clinical trial. Assures clear client and internal team communication, process documentation, and compliance with Good Clinical Practices and procedures set forth by IQVIA Biotech and its clients. ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES: Responsible for all activities related to implementation and execution of clinical studies that include: Client Duties/Responsibilities: Work with Project Manager (PM) to define program targets for clinical monitoring staff and assure work is documented within contracted project scope. Communicate and document all interactions with client as required by SOP. Serve as client advocate within IQVIA Biotech. Develop and implement Clinical Monitoring Plan. Team Duties/Responsibilities: Responsible for assuring needs of clinical sites are met by facilitating clinical monitoring processes, including: Coordinate site management activities: Site identification, recruitment, and selection. Regulatory document collection and review. Overall scheduling and management of all site visits. Develop site/monitoring tools and training materials. Review and identify trends in enrollment and data entry at sites and proactively interface with clinical monitoring team and client to identify solutions. Coordinate and oversee daily operations of clinical monitoring team: Set and enforce project timelines with the assigned study team. Coordinate remote review of clinical data within EDC system. Oversee monitoring visit schedule to ensure compliance with frequency set forth in contract. Review and approve trip reports and follow-up letters within required timeframe. Schedule and manage weekly CRA project team meetings. Ensure CRAs assigned to team receive therapeutic and project-specific training. Manage quality and regulatory compliance among clinical monitoring team and investigational sites. Manage project milestones and proactively address deficiencies: Attend and provide information at monthly projections meetings. Attend and provide information at weekly client teleconferences/team meetings. Assist Project Manager in identifying Out of Scope activities and assuring that such activities do not begin until the client provides authorization. Manage CRA performance: Define and implement functional standards, goals, and expectations with clinical monitoring team. Serve as CRA mentor and perform accompanied field assessment visits as required. Participate in the performance appraisal program by providing timely and accurate feedback regarding the performance of each respective CRA. Documentation Duties/Responsibilities: Assure that the appropriate IQVIA Biotech and/or sponsor SOPs are followed. Ensure all project documentation is appropriately filed per IQVIA Biotech SOPs. Assist PM in preparation of audit responses, as appropriate. Assist PM with preparation of information for inclusion in monthly report to client. Budget/Contract Duties/Responsibilities: Assist PM in review of project budgets, monitoring costs, potential overruns and propose/implement cost effective solutions. Define the scope of work with the client and clinical monitoring team. Assist PM in identifying and generating changes in scope and notify client of potential changes in scope. Review and approve CRA travel expenses and time sheets. KNOWLEDGE, SKILLS & ABILITIES: Thorough knowledge of clinical research process. Prior experience as a Clinical Research Associate. Strong communication skills (verbal and written) to express complex ideas. Excellent organizational and interpersonal skills. Positive attitude and ability to interact with all levels of staff to coordinate and execute study activities. Ability to manage multiple priorities within various clinical trials. Ability to reason independently and recommend specific solutions in clinical settings. Understanding of basic data processing functions, including electronic data capture. Working knowledge of current ICH GCP guidelines and applicable regulations. Able to mentor CRAs and more junior Clinical Trial Managers. Able to qualify for a major credit card. Valid driver’s license; ability to rent automobile. Willingness and ability to travel domestically and internationally, as required. CRITICAL JOB FUNCTIONS IN ACCORDANCE WITH ADA CRITERIA: Ability to travel domestically and internationally Very limited physical effort required to perform normal job duties MINIMUM RECRUITMENT STANDARDS: BS/BA (or equivalent) in one of the life sciences with a minimum of 4 years direct experience in clinical studies or equivalent level of education and experience. Minimum of 4 years as a Clinical Monitor/CRA, as well as experience in data handling or analysis. Minimum of 2 -3 years as a successful Clinical Trial Manager. Excellent verbal and written communication skills. Ability to work independently, prioritize and work with a matrix team environment is essential. Working knowledge of Word and Excel. Prior experience in electronic data capture (EDC) preferred. Therapeutic Knowledge- CAR T cell therapy study experience required; additionally 2 years of solid tumor, hematologic oncology and oncology phase I experience strongly preferred Join Us Making a positive impact on human health takes insight, curiosity, and intellectual courage. It takes brave minds, pushing the boundaries to transform healthcare. Regardless of your role, you will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve outcomes for patients. Forge a career with greater purpose, make an impact, and never stop learning. IQVIA is an EEO Employer - Minorities/Females/Protected Veterans/Disabled IQVIA, Inc. provides reasonable accommodations for applicants with disabilities. Applicants who require reasonable accommodation to submit an application for employment or otherwise participate in the application process should contact IQVIA’s Talent Acquisition team at [Click Here to Email Your Resumé] to arrange for such an accommodation. Job ID: R1089752

IQVIA™ is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward. Candidates must be based in Pennsylvania and have 2-3 years of monitoring experience in rare disease and pediatric experience required. Candidates should be within a 2 hour driving distance to Pittsburgh. BASIC FUNCTIONS: Participates in the preparation and execution of Phase I-IV clinical trials. Oversees the progress of clinical investigations by conducting pre-study, initiation, interim and close out visits to sites. Monitors clinical trials in accordance with Good Clinical Practices and procedures set forth by Iqvia Biotech and sponsors. Works closely with the Clinical Trial Manager to ensure all monitoring activities are conducted according to study requirements. ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES: • Participates in the investigator recruitment process. Performs initial qualification visits of potential investigators. Evaluates the capability of the site to successfully manage and conduct the clinical study, both clinically and technically • Assists in the preparation and review of protocols, eCRFs, study manuals, and other study documents as requested by Clinical Trial Manager • Works with the Study Start-up Group to coordinate activities with the site in preparation for the initiation of studies. Obtains and reviews regulatory documentation for successful implementation, monitoring, and evaluation of clinical trials. Works with Study Start-up Group and site staff to obtain regulatory (IRB/IEC) approval of study specific documents • Performs study initiation activities, reviewing with the site personnel the protocol, regulatory issues, study procedures, and provides training on completion of the eCRF; monitoring activities and study close-out activities • Trains site staff on the EDC system and verifies site computer system • Conducts periodic site file audits to ensure compliance with GCPs and Iqvia Biotech standard operating procedures • Assures adherence to Good Clinical Practices, investigator integrity, and compliance with all study procedures through on-site monitoring visits. Performs validation of source documentation as required by sponsor. Prepares monitoring reports and letters in a timely manner using approved Iqvia Biotech/sponsor forms and reports • Documents accountability, stability and storage conditions of clinical trial materials as required by sponsor. Performs investigational product inventory. Ensures return of unused materials to designated location or verifies destruction as required • Reviews the quality and integrity of the clinical data through (1) in house review of electronic CRF data and (2) on-site source verification. Works with sites to resolve data queries • Serves as primary contact between Iqvia biotech and investigator; coordinates all correspondence; ensures timely transmission of clinical data with the study site and technical reporting, as requested • Assists with, attends, and may present at Investigator Meetings for assigned studies • Performs study close-out visits • Serves as mentor for more junior CRAs as well as new CRAs to the project • May conduct field training and assessment of CRA Is and CRA IIs • Authorized to request site audits for reasons of validity • Performs other duties as requested KNOWLEDGE, SKILLS AND ABILILTIES: • Strong knowledge of clinical research process and medical terminology. • At least four years experience in monitoring clinical trials preferred. • Excellent written and verbal communication skills to express complex ideas to study personnel at research and clinical institutions. • Excellent organizational and interpersonal skills. • Ability to interact with all levels of staff to coordinate/execute study activities. • Ability to handle several priorities within multiple, complex clinical trials. • Ability to reason independently and recommend specific solutions in clinical settings. • Able to mentor other CRAs on project team and co-monitor as required. • Understanding of basic data processing functions, including electronic data capture. • Understanding of current GCP/ICH guidelines applicable to the conduct of clinical research. • Able to qualify for a major credit card. • Valid driver’s license; ability to rent automobile. • Willingness and ability to travel domestically and internationally, as required. CRITICAL JOB FUNCTIONS IN ACCORDANCE WITH ADA CRITERIA: • Ability to travel domestically and internationally. • Very limited physical effort required to perform normal job duties. MINIMUM RECRUITMENT STANDARDS: • BS/BA (or equivalent) in one of the life sciences with a minimum of 4 years of monitoring experience or equivalent amount of education/experience. • Must possess excellent verbal and written communication, interpersonal and organizational skills. • Requires an ability to work independently, prioritize, and work within a matrix team environment. • Computer literacy and knowledge of electronic data capture preferred. • Must be able to travel domestically and internationally 50-75%. Join Us Making a positive impact on human health takes insight, curiosity, and intellectual courage. It takes brave minds, pushing the boundaries to transform healthcare. Regardless of your role, you will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve outcomes for patients. Forge a career with greater purpose, make an impact, and never stop learning. IQVIA is an EEO Employer - Minorities/Females/Protected Veterans/Disabled IQVIA, Inc. provides reasonable accommodations for applicants with disabilities. Applicants who require reasonable accommodation to submit an application for employment or otherwise participate in the application process should contact IQVIA’s Talent Acquisition team at [Click Here to Email Your Resumé] to arrange for such an accommodation. Job ID: R1094912

IQVIA™ is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward. IQVIA Biotech has an excellent opportunity for an experienced Senior Clinical Trial Manager . This role requires 2-3 years of prior CTM experience and Dermatology experience in atopic dermatitis and/or psoriasis is strongly preferred. This is a fulltime regular position with competitive benefits package, and is remote-based. If you have a passion for helping smaller biotech companies move forward in their effort to get treatments to patients, then apply to IQVIA Biotech today for immediate consideration BASIC FUNCTIONS: Responsible for the successful planning, implementation and execution of contracted clinical monitoring activities. Functionally responsible for all clinical monitoring team members throughout the duration of each clinical trial. Assures clear client and internal team communication, process documentation, and compliance with Good Clinical Practices and procedures set forth by IQVIA Biotech and its clients. ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES: Responsible for all activities related to implementation and execution of clinical studies that include: Client Duties/Responsibilities: Work with Project Manager (PM) to define program targets for clinical monitoring staff and assure work is documented within contracted project scope. Communicate and document all interactions with client as required by SOP. Serve as client advocate within IQVIA Biotech. Develop and implement Clinical Monitoring Plan. Team Duties/Responsibilities: Responsible for assuring needs of clinical sites are met by facilitating clinical monitoring processes, including: Coordinate site management activities: Site identification, recruitment, and selection. Regulatory document collection and review. Overall scheduling and management of all site visits. Develop site/monitoring tools and training materials. Review and identify trends in enrollment and data entry at sites and proactively interface with clinical monitoring team and client to identify solutions. Coordinate and oversee daily operations of clinical monitoring team: Set and enforce project timelines with the assigned study team. Coordinate remote review of clinical data within EDC system. Oversee monitoring visit schedule to ensure compliance with frequency set forth in contract. Review and approve trip reports and follow-up letters within required timeframe. Schedule and manage weekly CRA project team meetings. Ensure CRAs assigned to team receive therapeutic and project-specific training. Manage quality and regulatory compliance among clinical monitoring team and investigational sites. Manage project milestones and proactively address deficiencies: Attend and provide information at monthly projections meetings. Attend and provide information at weekly client teleconferences/team meetings. Assist Project Manager in identifying Out of Scope activities and assuring that such activities do not begin until the client provides authorization. Manage CRA performance: Define and implement functional standards, goals, and expectations with clinical monitoring team. Serve as CRA mentor and perform accompanied field assessment visits as required. Participate in the performance appraisal program by providing timely and accurate feedback regarding the performance of each respective CRA. Documentation Duties/Responsibilities: Assure that the appropriate IQVIA Biotech and/or sponsor SOPs are followed. Ensure all project documentation is appropriately filed per IQVIA Biotech SOPs. Assist PM in preparation of audit responses, as appropriate. Assist PM with preparation of information for inclusion in monthly report to client. Budget/Contract Duties/Responsibilities: Assist PM in review of project budgets, monitoring costs, potential overruns and propose/implement cost effective solutions. Define the scope of work with the client and clinical monitoring team. Assist PM in identifying and generating changes in scope and notify client of potential changes in scope. Review and approve CRA travel expenses and time sheets. KNOWLEDGE, SKILLS & ABILITIES: Thorough knowledge of clinical research process. Strong communication skills (verbal and written) to express complex ideas. Excellent organizational and interpersonal skills. Positive attitude and ability to interact with all levels of staff to coordinate and execute study activities. Ability to manage multiple priorities within various clinical trials. Ability to reason independently and recommend specific solutions in clinical settings. Understanding of basic data processing functions, including electronic data capture. Working knowledge of current ICH GCP guidelines and applicable regulations. Ability to work independently, prioritize and work with a matrix team environment is essential. Working knowledge of Word and Excel. Prior experience in electronic data capture (EDC) preferred. Able to mentor CRAs and more junior Clinical Trial Managers. Able to qualify for a major credit card. Valid driver’s license; ability to rent automobile. Willingness and ability to travel domestically and internationally, as required. CRITICAL JOB FUNCTIONS IN ACCORDANCE WITH ADA CRITERIA: Ability to travel domestically and internationally Very limited physical effort required to perform normal job duties MINIMUM RECRUITMENT STANDARDS: BS/BA (or equivalent) in one of the life sciences and a minimum of 4 years direct experience in clinical studies Minimum of 4 years as a Clinical Monitor/CRA, as well as experience in data handling or analysis Minimum of 2 years as a successful Lead CRA or Clinical Trial Manager. Equivalent combination of education, training and experience CLASSIFICATION: This position is classified as exempt under the Fair Labor Standards Act; employees are not eligible for overtime compensation. Join Us Making a positive impact on human health takes insight, curiosity, and intellectual courage. It takes brave minds, pushing the boundaries to transform healthcare. Regardless of your role, you will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve outcomes for patients. Forge a career with greater purpose, make an impact, and never stop learning. IQVIA is an EEO Employer - Minorities/Females/Protected Veterans/Disabled IQVIA, Inc. provides reasonable accommodations for applicants with disabilities. Applicants who require reasonable accommodation to submit an application for employment or otherwise participate in the application process should contact IQVIA’s Talent Acquisition team at [Click Here to Email Your Resumé] to arrange for such an accommodation. Job ID: R1096899

IQVIA™ is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward. IQVIA Biotech is seeking a Principal Biostatistician with extensive experience (5 years) leading studies in Oncology, CVD, Immunology, or CNS in a CRO or pharmaceutical setting is preferred. BASIC FUNCTIONS: Provide statistical expertise and leadership to project and analysis team in one of the following areas: program lead over several studies, expertise in the analysis of data from a certain therapeutic area, expertise in a specific type of statistical analysis. Provide statistical consulting and technical support as it relates to the design and statistical analysis of clinical studies. Perform analyses, interpret study results, and collaborate with medical and Clinical Reporting staff to produce interim reports, final reports, and presentations. ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES: Collaborate with internal program staff and sponsors on the implementation and analysis of statistical aspects of research protocols. Provide statistical consultation for clinical programs, including but not limited to protocol development, randomization, sample size assessments, efficacy evaluations, and data review. Define and manage project timelines for specific projects, and ensure that project timelines are met for both internal and external clients. Ensure that project tasks are completed with superior quality for both internal and external clients. Review, approve and develop, as needed, the statistical analysis summary and analysis plans, including textual description of planned analysis and mock-ups of data displays. Oversee and/or perform statistical analyses, including hypothesis testing and modeling. Interact with Medical Writers to ensure appropriateness of data inferences and/or write pertinent sections of a clinical study report. Interface with clients and/or regulatory agencies as the project biostatistician. Ability to oversee a program of studies. Assist the Manager and Sr. Director in defining and maintaining departmental standards, SOPs and working practices. Provide leadership, mentoring and statistical support for Biostatistics staff. Assist the Manager and Sr. Director in development of training materials and execution of training in Biostatistics and general Clinical Reporting activities, for new and existing Clinical Reporting staff. Make presentations to clients and other interested individuals about the processes and procedures of the Clinical Reporting department. Assist the Manager in the coordination of project tasks and resources across the Biostatistics group, and act as backup during the Manager’s absence, as assigned. Perform other duties as assigned. KNOWLEDGE, SKILLS AND ABILITIES: Understanding of GCP, ICH, and FDA guidelines and regulations applicable to conduct clinical research. Advanced knowledge of statistical methods used in the design and analysis of Phase I – IV clinical trials. Experience with SAS Base and SAS Stat. Experience with other statistical software packages, such as N-Query, S-Plus. Ability to work creatively and independently to carry out assignments of a complex nature. Must be skilled in effective time management. Ability to work effectively and cooperatively with other professional staff members. Ability to communicate effectively, both verbally and in writing, with all levels of staff and with the public. CRITICAL JOB FUNCTIONS IN ACCORDANCE WITH ADA CRITERIA: Very limited physical effort required to perform normal job duties. MINIMUM RECRUITMENT STANDARDS: Degree requirements include one of the following: Masters-level degree in Statistics, Biostatistics or related field with eight years relevant CRO industry or biotech experience; or Doctorate-level degree in Statistics, Biostatistics or related field with six years relevant CRO industry or biotech experience. Data handling and analysis experience. Excellent interpersonal and organization skills. Join Us Making a positive impact on human health takes insight, curiosity, and intellectual courage. It takes brave minds, pushing the boundaries to transform healthcare. Regardless of your role, you will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve outcomes for patients. Forge a career with greater purpose, make an impact, and never stop learning. IQVIA is an EEO Employer - Minorities/Females/Protected Veterans/Disabled IQVIA, Inc. provides reasonable accommodations for applicants with disabilities. Applicants who require reasonable accommodation to submit an application for employment or otherwise participate in the application process should contact IQVIA’s Talent Acquisition team at [Click Here to Email Your Resumé] to arrange for such an accommodation. Job ID: R1083463

IQVIA™ is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward. Responsible for the successful planning, implementation and execution of contracted clinical monitoring activities for CAR-T cell therapy studies. Functionally responsible for all clinical monitoring team members throughout the duration of each clinical trial. Assures clear client and internal team communication, process documentation, and compliance with Good Clinical Practices and procedures set forth by IQVIA Biotech and its clients. ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES: Responsible for all activities related to implementation and execution of clinical studies that include: Client Duties/Responsibilities: Work with Project Manager (PM) to define program targets for clinical monitoring staff and assure work is documented within contracted project scope. Communicate and document all interactions with client as required by SOP. Serve as client advocate within IQVIA Biotech. Develop and implement Clinical Monitoring Plan. Team Duties/Responsibilities: Responsible for assuring needs of clinical sites are met by facilitating clinical monitoring processes, including: Coordinate site management activities: Site identification, recruitment, and selection. Regulatory document collection and review. Overall scheduling and management of all site visits. Develop site/monitoring tools and training materials. Review and identify trends in enrollment and data entry at sites and proactively interface with clinical monitoring team and client to identify solutions. Coordinate and oversee daily operations of clinical monitoring team: Set and enforce project timelines with the assigned study team. Coordinate remote review of clinical data within EDC system. Oversee monitoring visit schedule to ensure compliance with frequency set forth in contract. Review and approve trip reports and follow-up letters within required timeframe. Schedule and manage weekly CRA project team meetings. Ensure CRAs assigned to team receive therapeutic and project-specific training. Manage quality and regulatory compliance among clinical monitoring team and investigational sites. Manage project milestones and proactively address deficiencies: Attend and provide information at monthly projections meetings. Attend and provide information at weekly client teleconferences/team meetings. Assist Project Manager in identifying Out of Scope activities and assuring that such activities do not begin until the client provides authorization. Manage CRA performance: Define and implement functional standards, goals, and expectations with clinical monitoring team. Serve as CRA mentor and perform accompanied field assessment visits as required. Participate in the performance appraisal program by providing timely and accurate feedback regarding the performance of each respective CRA. Documentation Duties/Responsibilities: Assure that the appropriate IQVIA Biotech and/or sponsor SOPs are followed. Ensure all project documentation is appropriately filed per IQVIA Biotech SOPs. Assist PM in preparation of audit responses, as appropriate. Assist PM with preparation of information for inclusion in monthly report to client. Budget/Contract Duties/Responsibilities: Assist PM in review of project budgets, monitoring costs, potential overruns and propose/implement cost effective solutions. Define the scope of work with the client and clinical monitoring team. Assist PM in identifying and generating changes in scope and notify client of potential changes in scope. Review and approve CRA travel expenses and time sheets. KNOWLEDGE, SKILLS & ABILITIES: Thorough knowledge of clinical research process. Prior experience as a Clinical Research Associate. Strong communication skills (verbal and written) to express complex ideas. Excellent organizational and interpersonal skills. Positive attitude and ability to interact with all levels of staff to coordinate and execute study activities. Ability to manage multiple priorities within various clinical trials. Ability to reason independently and recommend specific solutions in clinical settings. Understanding of basic data processing functions, including electronic data capture. Working knowledge of current ICH GCP guidelines and applicable regulations. Able to mentor CRAs and more junior Clinical Trial Managers. Able to qualify for a major credit card. Valid driver’s license; ability to rent automobile. Willingness and ability to travel domestically and internationally, as required. CRITICAL JOB FUNCTIONS IN ACCORDANCE WITH ADA CRITERIA: Ability to travel domestically and internationally Very limited physical effort required to perform normal job duties MINIMUM RECRUITMENT STANDARDS: BS/BA (or equivalent) in one of the life sciences with a minimum of 4 years direct experience in clinical studies or equivalent level of education and experience. Minimum of 4 years as a Clinical Monitor/CRA, as well as experience in data handling or analysis. Minimum of 2 -3 years as a successful Clinical Trial Manager. Excellent verbal and written communication skills. Ability to work independently, prioritize and work with a matrix team environment is essential. Working knowledge of Word and Excel. Prior experience in electronic data capture (EDC) preferred. Therapeutic Knowledge- CAR T cell therapy study experience required; additionally 2 years of solid tumor, hematologic oncology and oncology phase I experience strongly preferred Join Us Making a positive impact on human health takes insight, curiosity, and intellectual courage. It takes brave minds, pushing the boundaries to transform healthcare. Regardless of your role, you will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve outcomes for patients. Forge a career with greater purpose, make an impact, and never stop learning. IQVIA is an EEO Employer - Minorities/Females/Protected Veterans/Disabled IQVIA, Inc. provides reasonable accommodations for applicants with disabilities. Applicants who require reasonable accommodation to submit an application for employment or otherwise participate in the application process should contact IQVIA’s Talent Acquisition team at [Click Here to Email Your Resumé] to arrange for such an accommodation. Job ID: R1089747

IQVIA™ is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward. IQVIA Biotech is seeking a full-time clinical research physician for the position of Medical Director or Senior Medical Director in any of the following therapeutic disciplines: Women’s Health/OB GYN; Pulmonary; Rheumatology. The Medical Director or Senior Medical Director provides medical and scientific support to clinical research programs, study teams and investigators. Additionally providing the review, advice, and leadership for potentially or actually awarded clinical research programs. The Medical Director or Senior Medical Director role is a team member participant role and functions in a matrix report to project teams much like other members of the project teams. The primary role of Medical Director or Senior Medical Director is to provide medical oversight for clinical trials by serving as Medical Monitor for studies conducted by Novella Clinical on behalf of sponsor companies. The principal function of a Medical Monitor is to serve as primary contact for the sponsor medical team and to serve as front line medical resource to support the project team. The Medical Monitor is customarily available 24/7 to answer questions from site coordinators and investigators on protocol inclusion/exclusion criteria, protocol clarifications, and compliance issues, and to provide review of alert labs per sponsor preference. Major duties of the Medical Director are outlined below: ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES: Functions as project team member Provides medical and scientific input to clinical research programs including review of new business proposals, preclinical and/or clinical data, study protocols, training materials, informed consent, Investigator Drug Brochures, eCRFs, analysis plan designs, clinical study reports, regulatory approval submissions, serious and non-serious adverse event evaluation and reporting Ensures medical activities run according to GCP and operate with highest efficiency Establishes and maintains a network of medical/scientific consultants, etc. Supervises and manages Medical Director activities Clinical Activities: Interacts with clients regarding drug development programs, study design and protocol Reviews and provides input for protocol development. Interacts with key thought leaders and/or sponsor representatives to develop inclusion/exclusion criteria and study endpoints. Interacts in team approach to develop statistical and data management sections of the protocol. Reviews the final protocol for clinical, safety and efficacy variables. Provides project team training on protocol and/or therapeutic areas Assists team with developing criteria for investigator site selection and networking for potential investigators for study participation. Aids in review and final selection. Participates in subject recruitment and retention activities including individual calls to key opinion leaders, investigators and site staff and/or participation in teleconference and WebEx presentations Presents protocol and/or safety reporting information at investigator meetings Develops project medical monitoring plans as requested Provides on call coverage for protocol queries and site support. Provides first line contact for investigators and monitors regarding study related medical/safety issues and resolution of study protocol and patient eligibility issues. Safety Monitoring and SAE Reporting Activities: Verifies the medical accuracy of patient safety data and maintains an ongoing assessment of the safety profile of the study Provides medical review of SAE reporting, writes and/or reviews SAE narratives, and works with the Safety Management Department to track SAEs and follow-up on outstanding safety queries, interacts with sponsor and discusses safety issues with site as needed Reviews IND/SUSAR Safety Reports (per sponsor preference), updates to Investigator Brochures, and annual IND reports with sponsor data In consultation with the sponsor, follow procedures for acquiring knowledge of subject treatment assignments (i.e. breaking the blind) Interact with appropriate FDA officials concerning safety and other study related issues, as requested Data Activities: Provides medical review of eCRFs for clinical accuracy Provides medical review of data analysis plan Reviews safety fields at case freeze for reconciliation (if needed) Works with data group to reconcile SAE events as needed Reviews medical coding of adverse events, laboratory data and concomitant medications for accuracy, coherence, consistency, and trends Reviews data tables, listings, and figures Reviews and/or writes portions of final clinical study report DSMB/Adjudication Committee Activities: May assist sponsor in choosing committee members May serve as a non-voting member to convene and organize proceedings May develop operating guidelines in conjunction with committee members and submits these to sponsor for review May determine data flow with sponsor to ensure reporting accuracy Can ensure DSMB feedback is given to sites for IRBs All DSMB activities are usually managed by the Novella Oversight Management Group and not the Novella medical monitor Business Development Activities Work with Business Development to actively solicit new business for Novella Clinical, including assistance with marketing presentations and proposal development Supports business development activities with proposal development and sales presentations Participates in feasibility discussions relating to specific project proposals Special Projects: Obtain literature searches to acquire background information for study proposals, preparation of training sessions, and interpretation of clinical data, report writing, etc. Assists with drafting of standard operating procedures and working practices regarding all Medical Director activities Participate in a variety of team quality improvement efforts as necessary Perform other related duties as assigned or requested by the Chief Medical Officer KNOWLEDGE, SKILLS, AND ABILITIES: Ability to work in partnership with a multidisciplinary group of colleagues, including translating concepts into practical approaches and promoting consensus Outstanding ability to work independently with minimal supervision, ability to work effectively within a team, and matrix environment Ability to organize and work efficiently on several projects, each with specific requirements and/or shifting priorities Excellent oral and written communications skills as well as interpersonal skills are essential CRITICAL JOB FUNCTIONS IN ACCORDANCE WITH ADA CRITERIA: Ability to travel domestically and internationally as required Very limited physical effort required to perform normal job duties MINIMUM RECRUITMENT STANDARDS: Current or prior license to practice medicine; Minimum 3-5 years of biopharmaceutical industry experience or academic experience in clinical research and drug development U. S. Board Certified/Eligible –Women’s Health/OB GYN; Pulmonary; Rheumatology Join Us Making a positive impact on human health takes insight, curiosity, and intellectual courage. It takes brave minds, pushing the boundaries to transform healthcare. Regardless of your role, you will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve outcomes for patients. Forge a career with greater purpose, make an impact, and never stop learning. IQVIA is an EEO Employer - Minorities/Females/Protected Veterans/Disabled IQVIA, Inc. provides reasonable accommodations for applicants with disabilities. Applicants who require reasonable accommodation to submit an application for employment or otherwise participate in the application process should contact IQVIA’s Talent Acquisition team at [Click Here to Email Your Resumé] to arrange for such an accommodation. Job ID: R1111870

IQVIA™ is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward. Responsible for the successful planning, implementation and execution of contracted clinical monitoring activities for CAR-T cell therapy studies. Functionally responsible for all clinical monitoring team members throughout the duration of each clinical trial. Assures clear client and internal team communication, process documentation, and compliance with Good Clinical Practices and procedures set forth by IQVIA Biotech and its clients. ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES: Responsible for all activities related to implementation and execution of clinical studies that include: Client Duties/Responsibilities: Work with Project Manager (PM) to define program targets for clinical monitoring staff and assure work is documented within contracted project scope. Communicate and document all interactions with client as required by SOP. Serve as client advocate within IQVIA Biotech. Develop and implement Clinical Monitoring Plan. Team Duties/Responsibilities: Responsible for assuring needs of clinical sites are met by facilitating clinical monitoring processes, including: Coordinate site management activities: Site identification, recruitment, and selection. Regulatory document collection and review. Overall scheduling and management of all site visits. Develop site/monitoring tools and training materials. Review and identify trends in enrollment and data entry at sites and proactively interface with clinical monitoring team and client to identify solutions. Coordinate and oversee daily operations of clinical monitoring team: Set and enforce project timelines with the assigned study team. Coordinate remote review of clinical data within EDC system. Oversee monitoring visit schedule to ensure compliance with frequency set forth in contract. Review and approve trip reports and follow-up letters within required timeframe. Schedule and manage weekly CRA project team meetings. Ensure CRAs assigned to team receive therapeutic and project-specific training. Manage quality and regulatory compliance among clinical monitoring team and investigational sites. Manage project milestones and proactively address deficiencies: Attend and provide information at monthly projections meetings. Attend and provide information at weekly client teleconferences/team meetings. Assist Project Manager in identifying Out of Scope activities and assuring that such activities do not begin until the client provides authorization. Manage CRA performance: Define and implement functional standards, goals, and expectations with clinical monitoring team. Serve as CRA mentor and perform accompanied field assessment visits as required. Participate in the performance appraisal program by providing timely and accurate feedback regarding the performance of each respective CRA. Documentation Duties/Responsibilities: Assure that the appropriate IQVIA Biotech and/or sponsor SOPs are followed. Ensure all project documentation is appropriately filed per IQVIA Biotech SOPs. Assist PM in preparation of audit responses, as appropriate. Assist PM with preparation of information for inclusion in monthly report to client. Budget/Contract Duties/Responsibilities: Assist PM in review of project budgets, monitoring costs, potential overruns and propose/implement cost effective solutions. Define the scope of work with the client and clinical monitoring team. Assist PM in identifying and generating changes in scope and notify client of potential changes in scope. Review and approve CRA travel expenses and time sheets. KNOWLEDGE, SKILLS & ABILITIES: Thorough knowledge of clinical research process. Prior experience as a Clinical Research Associate. Strong communication skills (verbal and written) to express complex ideas. Excellent organizational and interpersonal skills. Positive attitude and ability to interact with all levels of staff to coordinate and execute study activities. Ability to manage multiple priorities within various clinical trials. Ability to reason independently and recommend specific solutions in clinical settings. Understanding of basic data processing functions, including electronic data capture. Working knowledge of current ICH GCP guidelines and applicable regulations. Able to mentor CRAs and more junior Clinical Trial Managers. Able to qualify for a major credit card. Valid driver’s license; ability to rent automobile. Willingness and ability to travel domestically and internationally, as required. CRITICAL JOB FUNCTIONS IN ACCORDANCE WITH ADA CRITERIA: Ability to travel domestically and internationally Very limited physical effort required to perform normal job duties MINIMUM RECRUITMENT STANDARDS: BS/BA (or equivalent) in one of the life sciences with a minimum of 4 years direct experience in clinical studies or equivalent level of education and experience. Minimum of 4 years as a Clinical Monitor/CRA, as well as experience in data handling or analysis. Minimum of 2 -3 years as a successful Clinical Trial Manager. Excellent verbal and written communication skills. Ability to work independently, prioritize and work with a matrix team environment is essential. Working knowledge of Word and Excel. Prior experience in electronic data capture (EDC) preferred. Therapeutic Knowledge- CAR T cell therapy study experience required; additionally 2 years of solid tumor, hematologic oncology and oncology phase I experience strongly preferred Join Us Making a positive impact on human health takes insight, curiosity, and intellectual courage. It takes brave minds, pushing the boundaries to transform healthcare. Regardless of your role, you will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve outcomes for patients. Forge a career with greater purpose, make an impact, and never stop learning. IQVIA is an EEO Employer - Minorities/Females/Protected Veterans/Disabled IQVIA, Inc. provides reasonable accommodations for applicants with disabilities. Applicants who require reasonable accommodation to submit an application for employment or otherwise participate in the application process should contact IQVIA’s Talent Acquisition team at [Click Here to Email Your Resumé] to arrange for such an accommodation. Job ID: R1089746

IQVIA™ is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward. IQVIA Biotech clinical is seeking a part-time clinical research physician/contract consultant for the position of Clinical Research Medical Monitor. The Medical Monitor provides medical and scientific support to clinical research programs, study teams and investigators. The Medical Monitor also provides review, advice, and leadership for potentially or actually awarded clinical research programs. The Medical Monitor’s role is a team member participant role and functions in a matrix report to project teams much like other members of the project teams. Major duties of the Medical Monitor are outlined below: ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES: Serves as front line medical resource to support the project team and as primary contact for the sponsor medical team. Provides medical oversight for clinical trials by serving as Medical Monitor for studies conducted by IQVIA Biotech Clinical on behalf of sponsor companies. Provides medical and scientific input to clinical research programs including review of new business proposals, preclinical and/or clinical data, study protocols, training materials, informed consent, Investigator Drug Brochures, eCRFs, analysis plan designs, clinical study reports, regulatory approval submissions, serious and non-serious adverse event evaluation and reporting. Interacts with clients regarding study design and protocol. Ensures medical activities run according to GCP and operate with highest efficiency. Licensed M.D.; board certification Oncology/Hematology Minimum 3-5 years of biopharmaceutical industry experience or academic experience in clinical research and drug development Join Us Making a positive impact on human health takes insight, curiosity, and intellectual courage. It takes brave minds, pushing the boundaries to transform healthcare. Regardless of your role, you will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve outcomes for patients. Forge a career with greater purpose, make an impact, and never stop learning. IQVIA is an EEO Employer - Minorities/Females/Protected Veterans/Disabled IQVIA, Inc. provides reasonable accommodations for applicants with disabilities. Applicants who require reasonable accommodation to submit an application for employment or otherwise participate in the application process should contact IQVIA’s Talent Acquisition team at [Click Here to Email Your Resumé] to arrange for such an accommodation. Job ID: R1093207

IQVIA™ is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward. POSITION TITLE: (Senior) Medical Director REPORTS TO: VP, Medical IQVIA Biotech BASIC FUNCTIONS: The (Senior) Medical Director - Dermatologist, provides senior medical, clinical and scientific advisory expertise to IQVIA Biotech divisions. The (Senior) Medical Director provides medical oversight as the first line of support for clinical trials to which he/she is assigned as medical monitor. As such, the (Senior) Medical Director provides medical and scientific oversight of all aspects of Medical involvement on proposed and/or assigned studies including support of pre-award/proposal activities and support to study teams and investigators of awarded studies. The (Senior) Medical Director serves as a medical expert throughout business development activities by developing and supporting the medical strategy by providing review, advice, and leadership for potentially or actually awarded clinical research programs. Additionally, the (Senior) Medical Director provides medical and scientific support to clinical research programs, study teams and investigators. The (Senior) Medical Director is a team member participant role and functions in a matrix report to project teams much like other members of the project teams. The primary role of (Senior) Medical Director is to provide medical oversight for clinical trials by serving as Medical Monitor for studies conducted by IQVIA Biotech on behalf of sponsor companies. The principal function of a Medical Monitor is to serve as primary contact for the sponsor medical team and to serve as front line medical resource to support the project team. The Medical Monitor is customarily available 24/7 to answer questions from site coordinators and investigators on protocol inclusion/exclusion criteria, protocol clarifications, and compliance issues, and to provide review of alert labs per sponsor preference. Major duties of the (Senior) Medical Director are outlined below: ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES: Medical Monitoring: Clinical Activities: Participates in pre-award activities to support the acquisition of new business including working with Feasibility team members. Provides medical or scientific input into new business proposals. Attends and presents at bid defenses. Provides expert medical guidance for protocol or program development. Serves as Medical Monitor for awarded studies. Assists team with developing criteria for investigator site selection and networking for potential investigators for study participation. Aids in review and final selection as requested. Participates in subject recruitment and retention activities including individual calls to key opinion leaders, investigators and site staff and/or participation in teleconference and WebEx/Skype presentations as requested. Reviews and provides input for protocol development. Interacts with key thought leaders and/or sponsor representatives to develop inclusion/exclusion criteria and study endpoints. Interacts in team approach to develop statistical and data management sections of the protocol. Reviews the final protocol for clinical, safety and efficacy variables. Provides medically focused regulatory guidance and input re: regulatory submissions. Provides guidance to study team members and sponsors on the medical and scientific aspects of assigned projects. Provides first line contact for investigators and monitors regarding study related medical/safety issues and resolution of study protocol and patient eligibility issues for assigned studies. Serves as first point of escalation for the project team and sponsor for medically related matters of awarded work. Attends Kick-Off meetings and internal team and client meetings for assigned studies. Provides project team training on protocol and/or therapeutic areas. Develops project medical monitoring plans Attends and presents at Investigator Meetings for assigned studies. Provides medical and scientific input to study protocols, training materials, informed consent, Investigator Drug Brochures, eCRFs, analysis plan designs, clinical study reports, regulatory approval submissions, serious and non-serious adverse event evaluation and reporting as requested. Serves as Medical Safety Reviewer and/or Medical Data Reviewer for assigned studies as requested. Available 24 hours per day, 7 days per week to respond to urgent protocol-related issues at the investigative sites for assigned studies. Safety Monitoring and SAE Reporting Activities: Works with the IQVIA Biotech or vendor Safety Management Department to provide medical review and case assessment of SAEs including review and edits of SAE narratives and safety queries, follow-up on outstanding safety queries, and interacting with sponsors and sites to discuss safety issues with site as needed. Reviews IND/SUSAR Safety Reports (per sponsor preference), provide updates to Investigator Brochures, and annual IND reports with sponsor data as requested. In consultation with the sponsor, follows procedures for acquiring knowledge of subject treatment assignments (i.e. breaking the blind) as requested. Interacts with appropriate FDA officials concerning safety and other study related issues, as requested. Data Activities: Provides input into and guidance and review of work of the Medical Data Review Director and team members. Provides medical input into the development of eCRFs and edit check specifications for medical accuracy as requested. Reviews medical coding of adverse events, medical history and con meds for medical accuracy and consistency as requested. Reviews adverse events, laboratory data and concomitant medications and other sponsor requested data points for accuracy, coherence, consistency, and trends as requested. Provides medical review of the data analysis plan. Reviews safety fields at case freeze for reconciliation as requested. Works with the safety and data groups to reconcile SAE events as requested. Reviews data tables, listings, and figures as requested. Reviews and/or writes portions of final clinical study report as requested. KNOWLEDGE, SKILLS, AND ABILITIES: Ability to work in partnership with a multidisciplinary group of colleagues, including translating concepts into practical approaches and promoting consensus Outstanding ability to work independently with minimal supervision, ability to work effectively within a team, and matrix environment Ability to organize and work efficiently on several projects, each with specific requirements and/or shifting priorities Excellent oral and written communications skills as well as interpersonal skills are essential ​ CRITICAL JOB FUNCTIONS IN ACCORDANCE WITH ADA CRITERIA: Ability to travel domestically and internationally as required Very limited physical effort required to perform normal job duties MINIMUM RECRUITMENT STANDARDS: Current or prior license to practice medicine Board Certification/Eligibility in Dermatology Minimum 3-5 years of biopharmaceutical and/or Clinical Research Organization industry experience Academic experience in clinical research and drug development CLASSIFICATION: This position is classified as exempt under the Fair Labor Standards Act; employees are not eligible for overtime compensation. EU: N/A Join Us Making a positive impact on human health takes insight, curiosity, and intellectual courage. It takes brave minds, pushing the boundaries to transform healthcare. Regardless of your role, you will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve outcomes for patients. Forge a career with greater purpose, make an impact, and never stop learning. IQVIA is an EEO Employer - Minorities/Females/Protected Veterans/Disabled IQVIA, Inc. provides reasonable accommodations for applicants with disabilities. Applicants who require reasonable accommodation to submit an application for employment or otherwise participate in the application process should contact IQVIA’s Talent Acquisition team at [Click Here to Email Your Resumé] to arrange for such an accommodation. Job ID: R1102875

IQVIA™ is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward. BASIC FUNCTIONS: Participates in the preparation and execution of Phase I-IV clinical trials. Oversees the progress of clinical investigations by conducting site evaluation, initiation, and interim close out visits to sites. Monitors clinical trials in accordance with Good Clinical Practices and procedures set forth by IQVIA Biotech and sponsors. Works closely with the Clinical Trial Manager (CTM) and/or Lead CRA t0 ensure all monitoring activities are conducted according to study requirements. This position may also serve as Lead CRA. II ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES: Participates in the investigator recruitment process. Performs site evaluation visits of potential investigators. Evaluates the capability of the site to successfully manage and conduct the clinical study. Collaborates with the ISSC department to coordinate activities with the site in preparation for the initiation of the study. Obtains regulatory documentation for successful implementation, monitoring, and evaluation of clinical trials. Works with ISSC and site staff to obtain regulatory (IRB/IEC) approval of study specific documents Performs study initiation activities, reviewing with the site personnel the protocol, regulatory issues, study procedures, and provides training on completion of the eCRF; monitoring activities and study close-out activities. Trains site staff on the EDC system and verifies site computer system. Assists in resolving any issues to ensure compliance with site file audits in conjunction with ISSC. Assures adherence to Good Clinical Practices, investigator integrity, and compliance with all study procedures through on-site monitoring visits. Performs validation of source documentation as required by sponsor. Prepares monitoring reports and letters per the timelines defined in IQVIA Biotech SOPs by using approved IQVIA Biotech/sponsor templates and reports. Documents accountability, stability and storage conditions of clinical trial materials as required by sponsor. Performs investigational product inventory. Ensures return of unused materials to designated location or verifies destruction as required. Reviews the quality and integrity of the clinical data through (1) in house review of electronic CRF data and (2) on-site source verification. Works with sites to resolve data queries. Perform SAE review and reconciliation May review protocols, eCRFs, study manuals and other related documents, as requested by Clinical Trial Manager and/or Lead CRA. Serves as primary contact between IQVIA Biotech and investigator; coordinates all correspondence; ensures timely transmission of clinical data with the study site and technical reporting, as requested. Performs study close-out visits per the study specific Clinical Monitoring Plan including final investigational product reconciliation and disposition, site study file reconciliation, data query resolution through to database lock and resolution of outstanding action items. May assist with, and attend, Investigator Meetings for assigned studies. Attends study-related, company, departmental, and external meetings, as required. May serve as mentor for new clinical study monitors. Authorized to request site audits due to data integrity concerns. Ensure internal and study-related trainings are completed per IQVIA Biotech and/or study timelines; CTMS should always be current with the pertinent site updates/contacts. Ensure all study deliverables are completed per IQVIA Biotech and study timelines. LEAD CRA ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES: The Lead Clinical Research Associate may perform any of the following tasks: Participate in the investigator recruitment process. Perform site evaluation visits, as needed, of potential investigators. Evaluates the capability of the site to successfully manage and conduct the clinical study. Collaborate with the ISSC department to coordinate activities with the site in preparation for the initiation of the study. Obtains regulatory documentation for successful implementation, monitoring, and evaluation of clinical trials. Works with ISSC and site staff to obtain regulatory (IRB/IEC) approval of study specific documents Perform study initiation activities, reviewing with the site personnel the protocol, regulatory issues, study procedures, and provides training on completion of the eCRF; monitoring activities and study close-out activities. Assists with, and attends, Investigator Meetings for assigned studies. Train site staff on the EDC system and verify site computer system. Assist in resolving any issues to ensure compliance with site file audits in conjunction with ISSC. Assure adherence to Good Clinical Practices, investigator integrity, and compliance with all study procedures through on-site monitoring visits. Performs validation of source documentation as required by sponsor. Prepares monitoring reports and letters per the timelines defined in IQVIA Biotech SOPs by using approved IQVIA Biotech/sponsor templates and reports. Document accountability, stability and storage conditions of clinical trial materials as required by sponsor. Performs investigational product inventory. Ensures return of unused materials to designated location or verifies destruction as required. Review the quality and integrity of the clinical data through (1) in house review of electronic CRF data and (2) on-site source verification. Work with sites to resolve data queries. May review draft protocols, eCRFs, monitoring reports and follow-up letters, study manuals and other prepare study-related documents and templates, as requested by the CTM and/or PM. May serve as primary contact between IQVIA Biotech and investigator; coordinates all correspondence; ensures timely transmission of clinical data with the study site and technical reporting, as requested. Assist CTM and/or PM in review of project budgets, monitoring costs, potential overruns and propose/implement cost effective solutions. Assist the study management in identifying and generating changes in scope Perform study close-out visits per the study specific Clinical Monitoring Plan including final investigational product reconciliation and disposition, site study file reconciliation, data query resolution through to database lock and resolution of outstanding action items. Authorized to request site audits due to data integrity concerns. Attend study-related, company, departmental, and external meetings, as required. Ensure internal and study-related trainings are completed per IQVIA Biotech and/or study timelines; CTMS should always be current with the pertinent site updates/contacts. Ensure all study deliverables are completed per IQVIA Biotech and study timelines Conduct Field Evaluation Visits and field training of CRA Is, IIs and Sr CRAs. Serve as mentor for junior CRAs and those new to the company and/or study. Participate in the performance appraisal program by providing timely and accurate feedback regarding the performance of a perspective CRA. Review and approve CRA travel expenses and time sheets. Perform other duties, as requested. KNOWLEDGE, SKILLS AND ABILITIES: Knowledge of clinical research process and medical terminology. Strong written and verbal communication skills to express complex ideas to study personnel at research and clinical institutions. Good organizational and interpersonal skills. Ability to reason independently and recommend specific solutions in clinical settings. Ability to understand electronic data capture including basic data processing functions. Knowledge of current GCP/ICH guidelines applicable to the conduct of clinical research. Ability to qualify for a major credit card, rent an automobile PHYSICAL REQUIREMENTS: Very limited physical effort required to perform normal job duties Extensive use of telephone and face-to-face communication requiring accurate perception of speech Extensive use of keyboard requiring repetitive motion of fingers Regular sitting for extended periods of time MINIMUM RECRUITMENT STANDARDS: BS/BA/BSc (or equivalent) in one of the life sciences or health care background (RPh, RN, etc.) and a minimum of two (2) years of monitoring/site management experience is required; or an equivalent combination of education, training and experience. Must possess 2 years of cardiovascular and medical device experience. Experience in monitoring and/or coordinating clinical trials required. Must be able to travel domestically approximately 65%-85%. Valid driver’s license Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer CLASSIFICATION (US): This position is classified as exempt under the Fair Labor Standards Act; employees are not eligible for overtime compensation. Join Us Making a positive impact on human health takes insight, curiosity, and intellectual courage. It takes brave minds, pushing the boundaries to transform healthcare. Regardless of your role, you will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve outcomes for patients. Forge a career with greater purpose, make an impact, and never stop learning. IQVIA is an EEO Employer - Minorities/Females/Protected Veterans/Disabled IQVIA, Inc. provides reasonable accommodations for applicants with disabilities. Applicants who require reasonable accommodation to submit an application for employment or otherwise participate in the application process should contact IQVIA’s Talent Acquisition team at [Click Here to Email Your Resumé] to arrange for such an accommodation. Job ID: R1098111