- Serve as the primary Data Management contact for assigned clinical projects or programs.
- Oversee data entry processes, including guidelines, training, quality, and resourcing.
- Assess project timelines and resource needs, and help ensure clinical data management deadlines are met.
- Develop or oversee CRF specifications, database builds, user acceptance testing, and edit check specifications.
- Create, revise, version, and maintain data management documentation and oversee Trial Master File completeness.
- 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, and perform medical coding for consistency.
- Coordinate SAE/AE reconciliation and liaise with third-party vendors on timelines and data-related deliverables.
- Identify and troubleshoot operational issues using metrics, audit reports, and stakeholder input.
- Communicate with sponsors, vendors, and project teams about data, database, and project issues.
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