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Bristol Myers Squibb Clinical Data Manager Job, Life Sciences Apply Online
Hyderabad – TS – IN
Time Type: Full-time
Posted On: Posted Today
Job Requisition ID: R1587645
Responsibilities will include, but are not limited to:
Study Startup:
- 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, including but 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, and Protocol Data Review Plan (PDRP) post-study team review.
- Ensure all startup documents are completed as per SOP and filed in eTMF as per eTMF master plan.
Study Conduct:
- Plan/execute Post Production/Migration for the study (if any).
- Coordinate with Clinical Data Managers for the execution of data review tasks.
- Coordinate with external data vendors for any escalations related to 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 conduct Data Quality Review meetings.
- Provide Data Health Metrics to Data Management Lead as requested.
Study Closeout:
- Support Data Management Lead in planning and execution of database lock activities.
- Perform post-lock activities, as needed.
Project Management:
- Support DML in project management tasks to ensure the study is delivered successfully as per the study timelines with quality.
Documentation:
- Filing of appropriate documents in eTMF as per eTMF master plan.
Training and Mentorship:
- Provide training and mentoring to junior CDM staff.
Qualifications & Experience:
- Bachelor’s Degree required. Life Sciences, Pharmacy, or relevant fields preferred.
- 6 years of experience in managing end-to-end Clinical Data Management tasks.
- 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.
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