Director, Clinical Data Management
Bristol Myers Squibb
10 days ago
On-site
San Diego, CA
Clinical Research and Development
Director, Head of Clinical Data Management
Job Responsibilities
- Lead the Clinical Data Management function across the clinical portfolio.
- Serve as Data Management lead for a high-priority program with hands-on oversight of study execution, data review, issue resolution, and risk management.
- Lead NDA/BLA submission activities (readiness, data standards compliance, regulatory inspection preparedness).
- Partner cross-functionally with Clinical Operations, Biostatistics, Statistical Programming, Medical Monitoring, Safety, and Regulatory Affairs.
- Oversee CROs and vendors to ensure quality, compliance, accountability, and adherence to timelines/deliverables.
- Drive cross-functional data review and develop key data management documentation (DMPs, edit checks, validation specs, reconciliation plans, data transfer agreements).
- Develop scalable data management processes, standards, governance, and SOPs.
- Manage competing priorities; identify operational risks and mitigation strategies.
- Build and expand the Clinical Data Management team.
- Travel ~10%; evening/weekend work involved.
Skills and Knowledge
- EDC systems: Medidata RAVE or Veeva.
- GCP; CDISC/CDASH; ICH and FDA regulations.
- Strong communication, analytical, and problem-solving skills.
Basic Requirements
- BS/MS in Life Sciences, CS, Math, Health Sciences, or related field.
- 10+ years data management experience (pharma/biotech/CRO).
- Team leadership experience.
- Oncology therapeutic area experience.
- Manage CRO relationships and data management deliverables.
- Experience using AI-enabled tools.
Preferred Requirements
- Veeva EDC system experience.
- Radiopharmaceutical experience.
Compensation/Benefits (as stated)
- Princeton, NJ: $210,572–$255,164; San Diego, CA: $227,418–$275,577 (plus possible incentive cash/stock).
- Health coverage; wellbeing support; 401(k), disability, life/accident and other insurance.
- Paid Time Off; flexible time off/annual vacation options and additional eligible leave.
Work environment: moderate noise.
Job Responsibilities
- Lead the Clinical Data Management function across the clinical portfolio.
- Serve as Data Management lead for a high-priority program with hands-on oversight of study execution, data review, issue resolution, and risk management.
- Lead NDA/BLA submission activities (readiness, data standards compliance, regulatory inspection preparedness).
- Partner cross-functionally with Clinical Operations, Biostatistics, Statistical Programming, Medical Monitoring, Safety, and Regulatory Affairs.
- Oversee CROs and vendors to ensure quality, compliance, accountability, and adherence to timelines/deliverables.
- Drive cross-functional data review and develop key data management documentation (DMPs, edit checks, validation specs, reconciliation plans, data transfer agreements).
- Develop scalable data management processes, standards, governance, and SOPs.
- Manage competing priorities; identify operational risks and mitigation strategies.
- Build and expand the Clinical Data Management team.
- Travel ~10%; evening/weekend work involved.
Skills and Knowledge
- EDC systems: Medidata RAVE or Veeva.
- GCP; CDISC/CDASH; ICH and FDA regulations.
- Strong communication, analytical, and problem-solving skills.
Basic Requirements
- BS/MS in Life Sciences, CS, Math, Health Sciences, or related field.
- 10+ years data management experience (pharma/biotech/CRO).
- Team leadership experience.
- Oncology therapeutic area experience.
- Manage CRO relationships and data management deliverables.
- Experience using AI-enabled tools.
Preferred Requirements
- Veeva EDC system experience.
- Radiopharmaceutical experience.
Compensation/Benefits (as stated)
- Princeton, NJ: $210,572–$255,164; San Diego, CA: $227,418–$275,577 (plus possible incentive cash/stock).
- Health coverage; wellbeing support; 401(k), disability, life/accident and other insurance.
- Paid Time Off; flexible time off/annual vacation options and additional eligible leave.
Work environment: moderate noise.