Clinical Data Manager

About this role

Responsibilities

• Manage and lead all aspects of clinical trial data management activities from study start-up to database lock.
• Develop and implement data management plans, data validation plans, edit check plans and data entry guidelines in compliance with regulatory standards and company SOPs.
• Collaborate with cross-functional teams including Clinical Operations, Biostatistics, and Regulatory Affairs to ensure data quality and integrity throughout the trial lifecycle.
• Oversee Medidata Rave electronic data capture (EDC) system setup, configuration, user management, coding and data extracts.
• Perform data cleaning, discrepancy management, SAE and vendor integration reconciliation activities to ensure timely database lock.