Associate Director, Clinical Data Management

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.

Responsibilities will include, but are not limited to:

• Provides clinical data management leadership within the study team to align on and drive data collection requirements for one or more complex clinical development projects
• Efficiently plans, coordinates, and delivers complete, high quality and reliable clinical trial data in a timely manner for assigned projects
• Responsible for end‑to‑end clinical data management activities and serves as a primary point of contact for internal and external study team members
• May act as a driver to set program‑level data collection and review standards with cross‑functional team in partnership with global standards
• Provides strong quality and project oversight over third‑party vendor responsible for data management deliverables
• Takes a leadership role to gather content and integration requirements for EDC and close collaboration with partners supporting other data collection systems (eCOA, External Data, Safety Gateway). Enforces data standard conventions and quality expectations for clinical data per defined processes
• Authors, reviews/revises DM‑related study plans including Data Quality Management Plan, Data Validation Plans, Data Review Plan, eCRF Completion Guidelines and other study documents to ensure quality and standardization
• Chairs Data Quality Review meetings with cross‑functional study team members to ensure ongoing review of trial data currency, quality and completeness
• Represents DM on cross‑functional project teams & submission teams
• Lead or support the Health Authority inspections, audits, and CAPA implementation
• Provides coaching and quality oversight of junior Data Management Leads
• Lead or co‑chair the department Data Management Lead forums

• May act as core member of the study team and provides FSP/CRO/Vendor oversight for end‑to‑end Data Management activities, manages data currency throughout the trial, and overall monitoring DM deliverables according to the Service Level Agreement (SLA)
• May act as a functional representative and a point of contact for CRO and preferred vendors

• Supports change management initiatives with broad impact as a lead or participant in initiatives, and/or authors (or participates in) functional SOPs/WP/GD
• Utilizes knowledge of data management processes to evaluate and recommend new technologies and systems for improved data management functionality

• Able to work collaboratively on multi‑disciplinary project teams and develop productive relationships with external vendors
• Sound knowledge of Clinical Drug Development Process, FDA/ICH guidelines and industry standard practices regarding data management
• Strong knowledge and experience of EDC systems (Medidata RAVE preferred); demonstrated knowledge of Microsoft Office skills and well versed in industry trends and emerging technologies supporting data collection
• Strong project management; exhibits expertise in metrics analysis and reporting methodologies
• Excellent oral and written communication skills
• Communicates effectively with senior management and cross‑functional teams
• Knowledge of submission requirements, e.g. New Drug Application (NDA)/Biologics License Application (BLA)/Market Authorization Application (MAA)

• Bachelor’s Degree in life sciences, data science or statistics is required with an advanced degree preferred
• 7+ years of experience in Biopharma/CRO with 3+ years in study/program leadership role
• Travel: 5–10% Industry Conferences, Internal and Investigator Meetings, Regulatory Inspections (as needed)

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area