Associate Director, Clinical Data Management
Bristol Myers Squibb
8 hours ago
Remote friendly (Princeton, NJ)
United States
Clinical Research and Development
Position Summary:
The Associate Director, Clinical Data Management is a leadership role considered essential to the sustainability and success of the BMS R&D pipeline.
Key Responsibilities:
- Provide clinical data management leadership to align on and drive data collection requirements for complex clinical development projects.
- Plan, coordinate, and deliver complete, high-quality, reliable clinical trial data in a timely manner.
- Lead end-to-end clinical data management activities; primary point of contact for internal/external study team members.
- Set program-level data collection and review standards with cross-functional teams.
- Provide quality/project oversight of third-party vendors for data management deliverables.
- Gather and integrate requirements for EDC and collaborate with partners supporting eCOA, External Data, and Safety Gateway; enforce data standards.
- Author/revise DM study plans and documents (e.g., Data Quality Management Plan, Data Validation Plans, Data Review Plan, eCRF Completion Guidelines).
- Chair Data Quality Review meetings; ensure data currency, quality, and completeness.
- Represent DM on cross-functional project and submission teams.
- Lead/support Health Authority inspections, audits, and CAPA implementation.
- Coach junior Data Management Leads; lead/co-chair DM forums.
FSP/CRO/Vendor Oversight:
- Provide FSP/CRO/vendor oversight for end-to-end data management; monitor data currency and DM deliverables per SLA.
- Act as functional contact for CRO and preferred vendors.
Continuous Improvement:
- Support change management; author/participate in functional SOPs/WP/GD.
- Evaluate and recommend new technologies/systems to improve data management.
Qualifications & Experience:
- Bachelor’s degree in life sciences, data science, or statistics (advanced degree preferred).
- 7+ years Biopharma/CRO experience with 3+ years in study/program leadership role.
- Travel 5–10%.
Competency Requirements / Skills (Required/Preferred):
- Collaborative leadership across multidisciplinary teams and strong vendor relationships.
- Knowledge of clinical drug development process; FDA/ICH and data management industry practices.
- Strong EDC experience (Medidata RAVE preferred); Microsoft Office; awareness of emerging data collection technologies.
- Strong project management; metrics analysis and reporting.
- Excellent oral/written communication; effective communication with senior and cross-functional teams.
- Knowledge of submission requirements (e.g., NDA/BLA/MAA).
Benefits (explicitly stated):
- Health coverage (medical, pharmacy, dental, vision); wellbeing programs; 401(k), disability, life insurance, and other financial protection benefits.
- Paid time off (flexible time off/annual vacation and holidays per location/role).
Application Instructions:
- If you’re intrigued but don’t perfectly match your resume, apply anyway.
The Associate Director, Clinical Data Management is a leadership role considered essential to the sustainability and success of the BMS R&D pipeline.
Key Responsibilities:
- Provide clinical data management leadership to align on and drive data collection requirements for complex clinical development projects.
- Plan, coordinate, and deliver complete, high-quality, reliable clinical trial data in a timely manner.
- Lead end-to-end clinical data management activities; primary point of contact for internal/external study team members.
- Set program-level data collection and review standards with cross-functional teams.
- Provide quality/project oversight of third-party vendors for data management deliverables.
- Gather and integrate requirements for EDC and collaborate with partners supporting eCOA, External Data, and Safety Gateway; enforce data standards.
- Author/revise DM study plans and documents (e.g., Data Quality Management Plan, Data Validation Plans, Data Review Plan, eCRF Completion Guidelines).
- Chair Data Quality Review meetings; ensure data currency, quality, and completeness.
- Represent DM on cross-functional project and submission teams.
- Lead/support Health Authority inspections, audits, and CAPA implementation.
- Coach junior Data Management Leads; lead/co-chair DM forums.
FSP/CRO/Vendor Oversight:
- Provide FSP/CRO/vendor oversight for end-to-end data management; monitor data currency and DM deliverables per SLA.
- Act as functional contact for CRO and preferred vendors.
Continuous Improvement:
- Support change management; author/participate in functional SOPs/WP/GD.
- Evaluate and recommend new technologies/systems to improve data management.
Qualifications & Experience:
- Bachelor’s degree in life sciences, data science, or statistics (advanced degree preferred).
- 7+ years Biopharma/CRO experience with 3+ years in study/program leadership role.
- Travel 5–10%.
Competency Requirements / Skills (Required/Preferred):
- Collaborative leadership across multidisciplinary teams and strong vendor relationships.
- Knowledge of clinical drug development process; FDA/ICH and data management industry practices.
- Strong EDC experience (Medidata RAVE preferred); Microsoft Office; awareness of emerging data collection technologies.
- Strong project management; metrics analysis and reporting.
- Excellent oral/written communication; effective communication with senior and cross-functional teams.
- Knowledge of submission requirements (e.g., NDA/BLA/MAA).
Benefits (explicitly stated):
- Health coverage (medical, pharmacy, dental, vision); wellbeing programs; 401(k), disability, life insurance, and other financial protection benefits.
- Paid time off (flexible time off/annual vacation and holidays per location/role).
Application Instructions:
- If you’re intrigued but don’t perfectly match your resume, apply anyway.