Senior Manager, Clinical Data Management
vor 2 Monaten
Job Summary:
The Senior Manager, Clinical Data Management is a leadership role that plays a critical part in the success of Bristol Myers Squibb's R&D pipeline. This position is responsible for ensuring data quality, integrity, and completeness of all data types collected in clinical trials from study start to database lock.
Key Responsibilities:
- 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.
- Provides strong quality and project oversight over third-party vendors 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, and 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 and submission teams.
- Leads or supports Health Authority inspections and audits.
- Provides coaching and quality oversight of junior Data Management Leads.
- FSP/CRO/Vendor Oversight:
- May act as a 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).
- Continuous Improvement Initiatives:
- Provides relevant support and input to continuous improvement activities within clinical data management.
- Provides support for CAPA implementation as required.
Requirements:
- Bachelor's Degree required, with an advanced degree preferred.
- At least 5 years of relevant industry experience. Project management certification (e.g., PMP) is desirable.
- 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.
- Communicate 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)).
Travel Requirements: Yes, 5-10% Industry Conferences, Investigator Meetings, Regulatory Inspections (as needed).
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