Senior Manager, Clinical Data Management
Bristol Myers Squibb · Warsaw, Poland
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Role summary
Bristol Myers Squibb seeks a Senior Manager of Clinical Data Management to lead data collection and management activities across complex clinical development projects. This leadership role oversees end-to-end data management operations, vendor relationships, and cross-functional study teams to ensure high-quality, timely trial data.
What they're looking for
- Bachelor's degree required; advanced degree preferred
- Minimum 5 years of relevant clinical data management industry experience
- Strong expertise with EDC systems, particularly Medidata RAVE
- Proficiency with FDA/ICH guidelines and clinical drug development processes
- Project management certification (PMP) desirable
- Excellent written and oral communication with senior management and cross-functional teams
- Knowledge of regulatory submission requirements (NDA/BLA/MAA)
What you'll be doing
- Lead clinical data management strategy and oversight for one or more complex clinical development projects
- Plan, coordinate, and deliver complete, high-quality clinical trial data in timely manner across assigned projects
- Author and review data management study plans including Data Quality Management and Validation Plans
- Chair Data Quality Review meetings and represent data management on cross-functional project and submission teams
- Provide oversight and coaching to junior Data Management Leads and manage third-party vendor performance
Privacy & handoff
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