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Clinical Data Manager
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- Responsibilities: Mentor junior DMs and other project team members on areas related to data management; train site personnel on EDC system, eCRF, and additional tools such as ePRO when needed.
- Lead design of eCRF and review with study team to ensure design is robust and minimizes risk; work particularly closely with the lead statistician to translate study outcomes, protocol guidelines and prior build experience into eCRF design; lead electronic data capture (EDC) system design and validation, including oversight of all database specifications (eCRF design, edit checks, external data transfers, IWRS integration, etc
- Create and implement data management plans (DMPs), data validation plans (DVPs), and other study documents; ensure that the project team is trained and has a shared understanding of how data will be cleaned and each person's role in the process.
- Review and approve creation of edit checks, including validation of simple univariate and multivariate edit checks, programming of complex multivariate validation checks, and UAT of system edit checks.
- Review recommended data management tools and select the best tools for the study, leveraging study metadata and automation to minimize manual error and facilitate deeper understanding of study data.
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