Director, Clinical Data Management
Bristol Myers Squibb
9 days ago
Remote friendly (Princeton, NJ)
United States
Clinical Research and Development
Director, Head of Clinical Data Management
Job Responsibilities
- Lead the Clinical Data Management function, providing strategic and operational oversight across the clinical portfolio.
- Serve as Data Management lead for high-priority programs with hands-on involvement in execution, data review, issue resolution, and risk management.
- Lead NDA/BLA submission readiness, ensuring data standards compliance and regulatory inspection preparedness.
- Partner with Clinical Operations, Biostatistics, Statistical Programming, Medical Monitoring, Safety, and Regulatory Affairs to support execution and data quality objectives.
- Oversee CROs/vendors to ensure quality, compliance, accountability, timelines, and deliverables.
- Lead cross-functional data review and oversee key documentation (Data Management Plans, edit checks, validation specifications, reconciliation plans, data transfer agreements).
- Develop and implement scalable data management processes, standards, governance, and SOPs.
- Manage competing priorities across multiple studies; identify operational risks and mitigation strategies.
- Build and expand the Clinical Data Management team.
- Travel ~10%; evening/weekend work involved.
Skills & Knowledge
- EDC systems: Medidata RAVE or Veeva.
- GCP, CDISC/CDASH, ICH, FDA regulations.
- Strong communication; analytical/problem-solving.
Basic Requirements
- BS/MS in Life Sciences, Computer Science, Mathematics, Health Sciences, or related.
- 10+ years data management experience (pharma/biotech/CRO).
- Team leadership/management.
- Oncology therapeutic area experience.
- CRO relationship and data management deliverables experience.
- Experience with AI-enabled tools.
Preferred Requirements
- Veeva EDC experience.
- Radiopharmaceutical experience.
Benefits (explicitly listed)
- Health Coverage: medical, pharmacy, dental, vision.
- Wellbeing support and EAP.
- 401(k), disability, life insurance, and other listed protection programs.
- Paid Time Off; flexible time off/paid vacation options and other eligibility-based time-off.
Application Instructions
- Not specified in the role description.
Job Responsibilities
- Lead the Clinical Data Management function, providing strategic and operational oversight across the clinical portfolio.
- Serve as Data Management lead for high-priority programs with hands-on involvement in execution, data review, issue resolution, and risk management.
- Lead NDA/BLA submission readiness, ensuring data standards compliance and regulatory inspection preparedness.
- Partner with Clinical Operations, Biostatistics, Statistical Programming, Medical Monitoring, Safety, and Regulatory Affairs to support execution and data quality objectives.
- Oversee CROs/vendors to ensure quality, compliance, accountability, timelines, and deliverables.
- Lead cross-functional data review and oversee key documentation (Data Management Plans, edit checks, validation specifications, reconciliation plans, data transfer agreements).
- Develop and implement scalable data management processes, standards, governance, and SOPs.
- Manage competing priorities across multiple studies; identify operational risks and mitigation strategies.
- Build and expand the Clinical Data Management team.
- Travel ~10%; evening/weekend work involved.
Skills & Knowledge
- EDC systems: Medidata RAVE or Veeva.
- GCP, CDISC/CDASH, ICH, FDA regulations.
- Strong communication; analytical/problem-solving.
Basic Requirements
- BS/MS in Life Sciences, Computer Science, Mathematics, Health Sciences, or related.
- 10+ years data management experience (pharma/biotech/CRO).
- Team leadership/management.
- Oncology therapeutic area experience.
- CRO relationship and data management deliverables experience.
- Experience with AI-enabled tools.
Preferred Requirements
- Veeva EDC experience.
- Radiopharmaceutical experience.
Benefits (explicitly listed)
- Health Coverage: medical, pharmacy, dental, vision.
- Wellbeing support and EAP.
- 401(k), disability, life insurance, and other listed protection programs.
- Paid Time Off; flexible time off/paid vacation options and other eligibility-based time-off.
Application Instructions
- Not specified in the role description.