Full-Time Lead Data Manager

The Lead Data Manager (LDM) is responsible for providing oversight of all DM parts of a project from study start-up to database lock, working collaboratively with all functional groups.

Responsibilities:

• Provide updates for Data Management during internal/client team meetings.
• Provide metric reports for internal/external project team.
• Meet with the Project Manager to complete study objectives.
• Train other DM staff on project specific processes.
• Provide feedback to improve deliverables.
• Author/review data management documentation.
• Support design and testing of EDC study designs.
• Create listings/reports using ad hoc reporting tools.
• Communicate project risks or quality issues.
• Maintain project files and ensure traceability.
• Manage Lab ranges across the entire study.
• Perform data management activities (data review, SAE reconciliation, third party data reconciliation, query management).
• Oversee issuing of queries and review responses.

Requirements:

• 3-5 years of relevant experience in pharmaceutical industry/CRO, specifically in data management.
• Experience with EDC systems (e.g., Merative Zelta, Medrio, Medidata RAVE, iMednet, Datatrial).
• Proficiency in computer applications (Windows, Excel, Word, Outlook).

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