Senior Director, Clinical Data Management
Bristol Myers Squibb
September 02, 2026
Remote
United States
Clinical Research and Development
Responsibilities:
- Lead and oversee data management activities across the clinical portfolio, ensuring high-quality, timely, compliant deliverables.
- Provide strategic leadership for data management supporting NDA submissions (database lock, submission readiness, regulatory inspection preparedness).
- Build, lead, and develop the data management team (hiring, performance management, capability development).
- Serve as primary interface with external partners to align on data standards, processes, and resource planning.
- Oversee vendor strategy/performance (selection, budget management, timeline oversight, quality assurance).
- Standardize data management processes; develop and implement SOPs for scalable, inspection-ready operations.
- Establish/maintain database build, data cleaning, and data review processes for consistency and quality.
- Lead database strategy (build, validation, lock) for timely, high-quality delivery.
- Partner cross-functionally with Clinical Operations, Clinical Development, Biostatistics, and Safety to ensure aligned execution and data quality.
Required skills/knowledge:
- Strong experience with EDC systems (Medidata RAVE or Veeva).
- Solid knowledge of GCP, CDISC/CDASH, ICH guidelines, and FDA regulations.
- Excellent verbal and written communication.
- Strong analytical and problem-solving abilities.
Basic requirements:
- Bachelor’s or Master’s in Life Sciences, Computer Science, Mathematics, Health Sciences, or related field.
- Minimum 12 years data management experience in pharma/biotech/CRO.
- Demonstrated team leadership/management.
- In-depth Oncology therapeutic area experience.
- Proven ability to manage CRO relationships and oversee deliverables.
- Experience using AI-enabled tools to improve productivity.
Preferred:
- Veeva EDC system experience.
- Radiopharmaceutical experience.
Benefits (explicitly stated):
- Health coverage; wellbeing support; financial wellbeing/protection (incl. 401(k), disability, life insurance).
- Paid time off (flexible time off or 160 hours annual vacation depending on location/role type) plus holidays and additional eligible time off.
- Annual Global Shutdown between Christmas and New Year’s Day (eligibility-based).
- Lead and oversee data management activities across the clinical portfolio, ensuring high-quality, timely, compliant deliverables.
- Provide strategic leadership for data management supporting NDA submissions (database lock, submission readiness, regulatory inspection preparedness).
- Build, lead, and develop the data management team (hiring, performance management, capability development).
- Serve as primary interface with external partners to align on data standards, processes, and resource planning.
- Oversee vendor strategy/performance (selection, budget management, timeline oversight, quality assurance).
- Standardize data management processes; develop and implement SOPs for scalable, inspection-ready operations.
- Establish/maintain database build, data cleaning, and data review processes for consistency and quality.
- Lead database strategy (build, validation, lock) for timely, high-quality delivery.
- Partner cross-functionally with Clinical Operations, Clinical Development, Biostatistics, and Safety to ensure aligned execution and data quality.
Required skills/knowledge:
- Strong experience with EDC systems (Medidata RAVE or Veeva).
- Solid knowledge of GCP, CDISC/CDASH, ICH guidelines, and FDA regulations.
- Excellent verbal and written communication.
- Strong analytical and problem-solving abilities.
Basic requirements:
- Bachelor’s or Master’s in Life Sciences, Computer Science, Mathematics, Health Sciences, or related field.
- Minimum 12 years data management experience in pharma/biotech/CRO.
- Demonstrated team leadership/management.
- In-depth Oncology therapeutic area experience.
- Proven ability to manage CRO relationships and oversee deliverables.
- Experience using AI-enabled tools to improve productivity.
Preferred:
- Veeva EDC system experience.
- Radiopharmaceutical experience.
Benefits (explicitly stated):
- Health coverage; wellbeing support; financial wellbeing/protection (incl. 401(k), disability, life insurance).
- Paid time off (flexible time off or 160 hours annual vacation depending on location/role type) plus holidays and additional eligible time off.
- Annual Global Shutdown between Christmas and New Year’s Day (eligibility-based).