Bristol Myers Squibb Clinical Data Manager Job

Bristol Myers Squibb Clinical Data Manager Job, Pharma 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.

APPLY ONLINE HERE

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