- Serve as the primary data management contact for assigned clinical projects or programs, ensuring continuity, responsiveness, and timely completion of tasks.
- Oversee data entry processes, including guidelines, training, quality, and resourcing.
- Develop CRF specifications from study protocols and coordinate stakeholder review and feedback.
- Conduct database build user acceptance testing and maintain quality-controlled database documentation.
- Specify and oversee edit check and manual data review requirements and specifications.
- Create, revise, version, and maintain data management documentation, including Trial Master File documentation.
- Review and query clinical trial data according to the Data Management Plan, and perform line listing reviews.
- Run patient- and study-level status and metric reports; perform medical coding and coordinate SAE/AE reconciliation.
- Coordinate with sponsors, vendors, and project teams on data, database, timelines, and project deliverables.
- Identify and troubleshoot operational issues using metrics, audit reports, and stakeholder input.
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