Data Manager for Clinical Trials

Job Description

1. Acts as a communication line for project teams regarding clinical data management
2. Maintains TMF/eTMF
3. Trains Assistant Data Manager
4. Involved in clinical data management activities including, but not limited to:

• Supporting development of study documentation (eCRF Requirements, Edit Checks Specification, Data Management Plan, CRF Completion Guidelines, User Access Management Plan, Data Validation Plan, External Data Transfer Agreements, SAE Reconciliation Guidelines, Local Lab Normal Ranges Guidelines, Coding Guidelines where applicable)
• User acceptance testing
• User access management
• Data review
• eCRF/External data reconciliation
• Medical coding (for staff with medical/Life Science background)
• Supporting SAE reconciliation
• Query management
• Local lab normal ranges entry and QC
• Study Database Lock activities
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