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Clinical Data Manager
3-8 years
Hyderabad / Secunderabad
1 vacancy
Clinical Data Manager
Bristol-Myers Squibb
posted 8hr ago
Job Role Insights
Flexible timing
Key skills for the job
Job Description
- Research and Development (R&D), Global Drug Development (GDD), Global Development Operations (GDO), Global Data Management (GDM), Clinical Data Management (CDM)
- CDM is responsible for integrity, reliability, completeness and quality of clinical trial data and provides end to end clinical data management leadership for trials across the BMS R&D portfolio.
- The Clinical Data Manager is a Clinical Data Management team member role considered essential to complete data review tasks on assigned studies across therapeutic areas. This role will report to a line manager within CDM. It is a full- time office-based position with flexibility to work remotely up to 50% of the time over 2 weeks.
- Understand and review Protocol along with relevant data review documents (e.g. Protocol Data Review Plan, Data Quality Management Plan)
- Review clinical data listings.
- 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.
- Complete review of loaded external data.
- Track data load and address discrepancies.
- Coordinate with external data vendor for resolution of data discrepancies as applicable.
- Filing of appropriate documents in eTMF as per eTMF master plan.
- Bachelor s Degree required. Life sciences, Pharmacy or relevant fields preferred.
- 2 years of experience in Clinical Data Review tasks
- Able to work on clinical data review tasks
- Able to work collaboratively on multi-disciplinary project teams.
- Basic knowledge of Clinical Drug Development Process, FDA/ICH guidelines and industry standard practices regarding data management
- Good knowledge and experience of EDC systems (Medidata RAVE preferred); demonstrated knowledge of Microsoft Office skills.
- Good oral and written communication skills.
- Travel Required
- Describe Exposure to Any Hazards/disagreeable Conditions in the Work Environment
Employment Type: Full Time, Permanent
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