Associate Director, Clinical Data Management
Bristol Myers Squibb · Lawrence, NJ · 3 days ago
Information Technology$173k–$210k/yrFull-time
Job Responsibilities
- Provide data management leadership, insight, and support to all internal and external projects and clinical trials.
- May simultaneously function as lead Clinical Data Manager for multiple clinical trials.
- Responsible for ensuring the data collected meets the requirements of the study objective and company quality standards.
- Manage and provide oversight of data management personnel and activities of CROs and vendors.
- Ensure CRO adherence to project timelines, from study startup to study closeout, while maintaining high quality and integrity of deliverables.
- Engage in cross-functional meetings, providing updates on project status, issues, and milestones.
- Review data using listings and visualization tools for performance and quality reporting, conducting reviews within studies and across multiple studies for trend analysis.
- Lead interactions with third-party vendors (e.g., clinical laboratories) on collection, transmittal, and transfer of study-specific data.
- Proficient in clinical systems, including EDC, IVRS, CTMS, eTMF, and other clinical project management tools; ability to learn new systems as needed.
- Contribute to SOP development and updates to meet regulatory compliance and operational needs.
Basic Qualifications
- Bachelor’s degree
- Minimum of 6 years of data management experience in pharmaceutical/biotech/CRO industry
- Extensive hands-on experience in all aspects of data management.
Preferred Qualifications
- Bachelor’s degree in Life Science, mathematics, or health-related fields
- Experience in the Oncology therapeutic area
Skills And Qualifications
- Proven ability to manage CRO relationships and oversee data management deliverables.
- Strong knowledge and experience of EDC systems (Medidata RAVE or Veeva).
- 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.
- Applies AI to improve team execution and decision-making.
Physical Demands
- Regularly required to sit, reach with hands and arms, and talk or hear.
- Occasionally lift and/or move up to 25 pounds.