Senior Manager, Clinical Data Management

1 month ago

San Diego, California, United States Bristol Myers Squibb Full time
Job Summary

Bristol Myers Squibb is seeking a Senior Manager, Clinical Data Management to join our team. This role will be responsible for leading clinical data management activities, ensuring data quality, integrity, and completeness, and collaborating with cross-functional teams to drive project success.

Key Responsibilities
  • Lead clinical data management activities, including data collection, validation, and reporting.
  • Collaborate with cross-functional teams, including study teams, vendors, and regulatory agencies, to ensure data quality and integrity.
  • Develop and implement data management plans, including data validation plans, data review plans, and eCRF completion guidelines.
  • Chair data quality review meetings with cross-functional study team members to ensure ongoing review of trial data currency, quality, and completeness.
  • Represent DM on cross-functional project teams and submission teams.
  • Lead or support Health Authority inspections and audits.
  • Provide coaching and quality oversight of junior Data Management Leads.
Requirements
  • Bachelor's Degree required, advanced degree preferred.
  • At least 5 years of relevant industry experience.
  • Project management certification (e.g. PMP) is desirable.
  • 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 and well-versed in industry trends and emerging technologies supporting data collection.
  • Strong project management; expertise in metrics analysis and reporting methodologies.
  • Excellent oral and written communication skills.
  • Communicate effectively with senior management and cross-functional teams.
  • Knowledge of submission requirements, e.g. New Drug Application (NDA)/Biologics License Application (BLA)/Market Authorization Application (MAA).
Travel Required

Yes, 5-10% Industry Conferences, Investigator Meetings, Regulatory Inspections (as needed).

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