We are a Medical Device/Biotech company headquartered out of San Diego, CA. Our focus is developing minimally invasive surgical products for the spine, as well as orthopedics. We have also branched out into the neuromonitoring space in the past few years. Since our inception in 1999, we continue to outperform the market as the largest, spine focused company in the world. With more than $1 billion in revenues, NuVasive has approximately 2,800 employees and operates in more than 50 countries serving surgeons, hospitals and patients.
Our employees directly influence our growth and innovation, significantly contribute to the success of the company, and actively support our vision. With a focus on building meaningful career experiences for our employees, our investment in diversity and inclusion, our commitment to supporting under-resourced communities around the globe with the NuVasive Spine Foundation, and our support of patients with The Better Way Back, we are passionate about helping our employees have purpose and most importantly—thrive! Seeking an experienced Clinical Data Manager to join our team!
The Clinical Data Manager will be responsible for data management activities including, but not limited to, developing data management plans and dictionaries, performing database development, testing, validation, and processing and reviewing clinical study data to ensure the completeness, accuracy and consistency of the data for subsequent analysis and reporting.
Develops study specific Data Management Plan (DMP), Case Report Form (CRF) completion guidelines, annotated CRFs, database documentation, edit check specifications, data transfer processes and data entry instructions
Designs clinical study databases according to industry-standard methods of clinical data collection, data flow, data mapping, data output, and data lock, and according to specifications outlined in the DMP
Performs database testing, validation, and site training and support
Programs edit checks for data cleaning. Writes or develops or supervises programming to generate tables and listings to facilitate data cleaning
Manages data query resolution
Manages internal and external data transfer processes, and reconciles data tables from different sources
Works closely with Clinical Operations, Data Analytics and other teams as appropriate to develop databases to ensure the required information is captured and formatted for statistical analysis. Work with Data Analytics to compile and maintain the data dictionary
Responsible for filing and maintaining scoring methodologies and references
Maintains multiple study databases and data management activities concurrently
Coordinates and completes data management activities to meet project timelines
Participates in clinical review and validation of statistical outputs used in the preparation of final reports.
Writes and reviews SOPs and WIs as needed
Performs other duties as assigned
High level expertise in EDC systems
Experience with electronic TMF systems
Understands the regulatory environment in the context of data management compliance (e.g., 21 CFR Part 11 Compliance)
Ability to collaborate across different department teams (e.g., marketing, product development)
Strong ability to multitask and work effectively in a fast-paced environment with changing priorities
Typically requires a minimum of 8 years of related experience with a Bachelor’s degree; or 6 years and a Master’s degree; or a PhD with 3 years’ experience; or equivalent experience
Experience in a clinical or industry setting within the medical device industry
Related experience with patient registry data
SAS programming skills or knowledge of any other programming language
Familiarity with Medrio and/or iMedNet EDC systems
Familiarity with coding dictionaries (MedDRA, WHO Drug)
Knowledge of spine surgery research
Familiarity with CDISC STDM and ADaM