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Associate Manager, Clinical Data Management
3-6 years
Hyderabad / Secunderabad
1 vacancy
Associate Manager, Clinical Data Management
Bristol-Myers Squibb
posted 8hr ago
Job Role Insights
Flexible timing
Key skills for the job
Job Description
- Draft EDC build timeline in collaboration with Data Management Lead.
- Perform DB build tasks by creating specifications for Database and Edit Checks.
- Create test scripts and complete test data entry/UAT for Coding, Site Payment, Safety Gateway.
- Collaborate with Data Management Lead and facilitate startup meetings which includes, not limited to, EDC build kick-off, Interactive eCRF Build and IRMs (Interactive Review Meeting) for database and Edit checks.
- Create and finalize study documents like Data Quality Management Plan, eCRF completion Instructions, Protocol Data Review Plan (PDRP) post study team review.
- Ensure all startup documents are completed as per SOP and filled in eTMF as per eTMF master plan.
- Plan/execute Post Production/Migration for the study (if any).
- Coordinate with Clinical Data Managers for the execution of data review tasks.
- Coordidate with external data vendors for any escalations related to any vendor data.
- Support Clean Patient Group delivery along with Clinical Data Management staff.
- Update study documents as needed during the conduct of the study
- Support DML to coduct Data Quality Review meetings.
- Provide Data Health Metrics to Data Management Lead as requested.
- Support Data Management Lead in planning and execution of database lock activities.
- Perform post lock activities, as needed.
- Support DML in project management tasks to make sure that study is delivered successfully as per the study timelines with quality.
- Filing of appropriate documents in eTMF as per eTMF master plan.
- Provide Training and mentoring to junior CDM staff.
- Able to work on end to end Clinical Data Management 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.
- Strong project management skills
Employment Type: Full Time, Permanent
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