Associate Director, Clinical Data Management
Bristol Myers Squibb
8 months ago
Remote friendly (Princeton, NJ)
United States
Clinical Research and Development
Associate Director, Clinical Data Management
Responsibilities:
- Provide data management leadership, insight, and support to internal and external projects and clinical trials.
- Serve as lead Clinical Data Manager for multiple clinical trials (as needed).
- Ensure collected data meets study objective requirements and company quality standards.
- Manage and provide oversight of data management personnel and CROs/vendors.
- Ensure CRO adherence to project timelines from study startup through closeout while maintaining high-quality, integrity of deliverables.
- Participate in cross-functional meetings; provide updates on status, issues, and milestones.
- Review data using listings and visualization tools for performance and quality reporting; conduct intra- and inter-study reviews for trend analysis.
- Lead interactions with third-party vendors (e.g., clinical laboratories) on collection, transmittal, and transfer of study-specific data.
- Use clinical systems including EDC, IVRS, CTMS, eTMF, and other clinical project management tools (learn new systems as needed).
- Contribute to SOP development and updates to meet regulatory compliance and operational needs.
- 10% travel required.
Qualifications:
- Bachelor’s degree in Life Science, mathematics, or health-related fields (preferred).
- Minimum 6 years of data management experience in pharmaceutical/biotech/CRO, with hands-on experience in all aspects of data management.
- Experience in Oncology therapeutic area (preferred).
- Proven ability to manage CRO relationships and oversee data management deliverables.
- Strong knowledge/experience of EDC systems (Medidata RAVE preferred).
- Solid knowledge of GCP, CDISC/CDASH data structures, ICH guidelines, and FDA regulations.
- Excellent verbal and written communication skills.
- Strong analytical and problem-solving abilities.
Skills/Systems:
- EDC (Medidata RAVE preferred), IVRS, CTMS, eTMF, clinical data visualization/listings, SOP development.
Benefits (explicitly listed):
- Health coverage (medical, pharmacy, dental, vision); wellbeing support programs; financial protection (401(k), disability, life/accident/supplemental insurance, travel protection, identity theft benefit, legal support, survivor support).
- Paid Time Off: flexible time off (unlimited for US exempt employees with manager approval) or 160 hours annual paid vacation (for certain roles), paid national holidays; additional time off may include unlimited paid sick time, volunteer days, summer hours flexibility, leaves of absence, and annual Global Shutdown.
Application instructions:
- Apply for requisition R1599661 (Associate Director, Clinical Data Management).
Responsibilities:
- Provide data management leadership, insight, and support to internal and external projects and clinical trials.
- Serve as lead Clinical Data Manager for multiple clinical trials (as needed).
- Ensure collected data meets study objective requirements and company quality standards.
- Manage and provide oversight of data management personnel and CROs/vendors.
- Ensure CRO adherence to project timelines from study startup through closeout while maintaining high-quality, integrity of deliverables.
- Participate in cross-functional meetings; provide updates on status, issues, and milestones.
- Review data using listings and visualization tools for performance and quality reporting; conduct intra- and inter-study reviews for trend analysis.
- Lead interactions with third-party vendors (e.g., clinical laboratories) on collection, transmittal, and transfer of study-specific data.
- Use clinical systems including EDC, IVRS, CTMS, eTMF, and other clinical project management tools (learn new systems as needed).
- Contribute to SOP development and updates to meet regulatory compliance and operational needs.
- 10% travel required.
Qualifications:
- Bachelor’s degree in Life Science, mathematics, or health-related fields (preferred).
- Minimum 6 years of data management experience in pharmaceutical/biotech/CRO, with hands-on experience in all aspects of data management.
- Experience in Oncology therapeutic area (preferred).
- Proven ability to manage CRO relationships and oversee data management deliverables.
- Strong knowledge/experience of EDC systems (Medidata RAVE preferred).
- Solid knowledge of GCP, CDISC/CDASH data structures, ICH guidelines, and FDA regulations.
- Excellent verbal and written communication skills.
- Strong analytical and problem-solving abilities.
Skills/Systems:
- EDC (Medidata RAVE preferred), IVRS, CTMS, eTMF, clinical data visualization/listings, SOP development.
Benefits (explicitly listed):
- Health coverage (medical, pharmacy, dental, vision); wellbeing support programs; financial protection (401(k), disability, life/accident/supplemental insurance, travel protection, identity theft benefit, legal support, survivor support).
- Paid Time Off: flexible time off (unlimited for US exempt employees with manager approval) or 160 hours annual paid vacation (for certain roles), paid national holidays; additional time off may include unlimited paid sick time, volunteer days, summer hours flexibility, leaves of absence, and annual Global Shutdown.
Application instructions:
- Apply for requisition R1599661 (Associate Director, Clinical Data Management).