Lead Data Manager (Expert in working & developing EDC systems)
2 months ago
The Lead Data Manager (LDM) within the ERGOMED Data Management (DM) department is responsible for providing oversight of all DM parts of a project fro.....
- The Lead Data Manager (LDM) within the ERGOMED Data Management (DM) department is responsible for providing oversight of all DM parts of a project from study start-up to database lock by working in a collaborative team environment with all functional groups.
- The Lead Data Manager represents a position under direction of the Director of Data Management.
- Provide updates for Data Management during internal/client team meetings and communication if required.
- Provides metric reports for internal/external project team
- Meets with the Project Manager to work on completing the study objectives in a timely manner
- Provides training of other DM staff on project specific processes
- Provides feedback to other project team members and managers to improve the deliverables
- Authors or reviews data management documentation including the Data Management Plan,
- Data Review Plan, eCRF Completion Guidelines, and others as needed
- Supports build, design and testing of EDC study designs
- Creates listings/reports using ad hoc reporting tools across multiple EDC systems
- Communicates any project risks or possible quality issues to the Project Manager
- May work on projects across multiple trial EDC platforms
- Maintains project files and ensures full traceability of all processes and documentation
- Manages Lab ranges across the entire study
- Performs data management activities such as data review, serious adverse event reconciliation, third party electronic data (e.g. laboratory, PK, diary) reconciliation, and query management
- Oversees the issuing of queries and reviews query responses with the highest level of quality
- Perform DM and/or EDC activities if needed, provided the required experience and background are in place
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