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Senior Manager, Clinical Data Management

vor 1 Monat


Boudry District, Schweiz Bristol Myers Squibb Vollzeit

Clinical Data Management Overview

Clinical Data Management is a critical function at Bristol Myers Squibb, ensuring the quality, integrity, and completeness of data collected in clinical trials. As a Senior Manager, Clinical Data Management, you will play a key role in driving data collection requirements, planning, coordinating, and delivering high-quality clinical trial data.

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)
  • 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

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)