Regeneron Pharmaceuticals - Armonk, NY

posted 25 days ago

Full-time - Senior
Armonk, NY
Professional, Scientific, and Technical Services

About the position

The Associate Director, Program Data Management Lead is responsible for the strategic management and leadership of clinical data management activities within assigned programs. This role involves overseeing data management processes, ensuring quality and compliance with regulations, and managing resources and timelines for clinical research studies. The PDML collaborates with senior management, external vendors, and clinical study personnel to ensure the success of clinical programs.

Responsibilities

  • Responsible for the overall success of the studies within a program(s) for Clinical Data Management (CDM).
  • Maintains an overview of clinical program(s) status and issues, proactively communicating progress, risks, issues, or changes that may impact quality, timelines, and/or budget.
  • Review plans and provide CDM expertise during protocol design, study start-up, and conduct phases of studies.
  • Ensure consistency within the program and development of standard methodologies within CDM.
  • Ensure quality results, implement timelines, and ensure consistency of process and approaches across clinical study results.
  • Leads all aspects of program level result timelines, ensuring proper resources are in place and supervising overlapping deliverables.
  • Oversees CDM study budgets within a program, ensuring review of initial study budget and handling the budget through the lifecycle of the program.

Requirements

  • Bachelor's degree in Mathematics, Science, or a related field.
  • Minimum of 12 years of clinical data management experience in biotechnology, pharmaceutical, or health-related industry.

Benefits

  • Health and wellness programs
  • Fitness centers
  • Equity awards
  • Annual bonuses
  • Paid time off
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