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Senior Clinical Data Manager
5-8 years
Hyderabad / Secunderabad
1 vacancy
Senior Clinical Data Manager
Bristol-Myers Squibb
posted 8hr ago
Job Role Insights
Flexible timing
Key skills for the job
Job Description
- Understand and review Protocol along with relevant study specific data review documents.
- Provide input to data review documents like Protocol Data Review Plan, Data Quality Management Plan
- Review clinical data listings and prioritize critical data review.
- Manage and facilitate resolution of data discrepancies.
- Perform data cleaning as per the defined Clean Patient Group.
- Freezing & Locking of CRFs/Fields.
- Coordinate with Data Management Lead for study deliverables.
- Track data load and address discrepancies.
- Complete review of loaded external data and prioritize complex external data review e.g. Blinded Independent Committee Review, Biomarker, SAE
- Coordinate with external data vendor for resolution of data discrepancies as applicable.
- Filing of appropriate documents in eTMF as per eTMF master plan.
- Provide Training and mentoring to junior CDM staff.
- Able to work on clinical data review tasks
- Able to work collaboratively on multi-disciplinary project teams.
- Strong knowledge of Clinical Drug Development Process, FDA/ICH guidelines and industry standard practices regarding data management
- Strong knowledge and experience of EDC systems (Medidata RAVE preferred); demonstrated knowledge of Microsoft Office skills.
- Strong oral and written communication skills.
Employment Type: Full Time, Permanent
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