Associate Director, Clinical Data Management
Bristol Myers Squibb
5 days ago
Remote friendly (Madison, NJ)
United States
Clinical Research and Development
Position Summary
Associate Director, Clinical Data Management (leadership role for the sustainability and success of the BMS R&D pipeline).
Key Responsibilities
- Lead clinical data management within study teams; align and drive data collection requirements for complex clinical development projects.
- Plan, coordinate, and deliver complete, high-quality, reliable clinical trial data on time.
- Own end-to-end clinical data management activities; primary contact for internal/external study team members.
- Define program-level data collection and review standards with cross-functional teams.
- Provide quality/project oversight for third-party data management vendors; ensure deliverables per SLA.
- Lead EDC content/integration requirements and collaborate with eCOA, External Data, Safety Gateway partners; enforce data standards/quality.
- 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 (currency, quality, completeness); represent DM on cross-functional and submission teams.
- Lead/support Health Authority inspections, audits, and CAPA implementation.
- Coach junior Data Management Leads; lead/co-chair Data Management Lead forums.
Competency/Qualifications (Required/Preferred)
- Bachelor’s in life sciences/data science/statistics (advanced degree preferred).
- 7+ years Biopharma/CRO with 3+ years in study/program leadership.
- Knowledge of clinical drug development process; FDA/ICH and industry data management practices.
- Strong EDC experience (Medidata RAVE preferred); Microsoft Office; emerging data-collection technologies.
- Strong project management; metrics analysis/reporting; excellent written/oral communication.
- Communicate effectively with senior management and cross-functional teams.
- Knowledge of submission requirements (e.g., NDA/BLA/MAA).
Travel
- 5–10% (conferences, meetings, regulatory inspections as needed).
Benefits (explicitly listed)
- Health coverage (medical/pharmacy/dental/vision), wellbeing support, 401(k), disability, life insurance, and other protections.
- Paid time off (flexible/unlimited options for US exempt roles; annual vacation/holidays for some roles).
Application Instruction
- If the role isn’t a perfect match, apply anyway.
Associate Director, Clinical Data Management (leadership role for the sustainability and success of the BMS R&D pipeline).
Key Responsibilities
- Lead clinical data management within study teams; align and drive data collection requirements for complex clinical development projects.
- Plan, coordinate, and deliver complete, high-quality, reliable clinical trial data on time.
- Own end-to-end clinical data management activities; primary contact for internal/external study team members.
- Define program-level data collection and review standards with cross-functional teams.
- Provide quality/project oversight for third-party data management vendors; ensure deliverables per SLA.
- Lead EDC content/integration requirements and collaborate with eCOA, External Data, Safety Gateway partners; enforce data standards/quality.
- 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 (currency, quality, completeness); represent DM on cross-functional and submission teams.
- Lead/support Health Authority inspections, audits, and CAPA implementation.
- Coach junior Data Management Leads; lead/co-chair Data Management Lead forums.
Competency/Qualifications (Required/Preferred)
- Bachelor’s in life sciences/data science/statistics (advanced degree preferred).
- 7+ years Biopharma/CRO with 3+ years in study/program leadership.
- Knowledge of clinical drug development process; FDA/ICH and industry data management practices.
- Strong EDC experience (Medidata RAVE preferred); Microsoft Office; emerging data-collection technologies.
- Strong project management; metrics analysis/reporting; excellent written/oral communication.
- Communicate effectively with senior management and cross-functional teams.
- Knowledge of submission requirements (e.g., NDA/BLA/MAA).
Travel
- 5–10% (conferences, meetings, regulatory inspections as needed).
Benefits (explicitly listed)
- Health coverage (medical/pharmacy/dental/vision), wellbeing support, 401(k), disability, life insurance, and other protections.
- Paid time off (flexible/unlimited options for US exempt roles; annual vacation/holidays for some roles).
Application Instruction
- If the role isn’t a perfect match, apply anyway.