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Director / Associate Director Clinical Operations

Apex Systems
Cambridge, MA Full Time
POSTED ON 3/10/2025
AVAILABLE BEFORE 6/6/2025

Job# : 2053911

Job Description :

Director / Associate Director Clinical Operations 2053911

Location :  Watertown, MA (Hybrid)

Focus :  Immunology / Inflammation

Job Overview : The Clinical Operations Manager will lead our client’s clinical development programs, oversee trials from design to execution, and manage CROs, budgets, and regulatory submissions.

Primary Job Responsibilities :

  • Lead clinical trial operations, ensuring timely and compliant execution.
  • Coordinate with CROs to meet development timelines and budgets.
  • Design protocols and oversee regulatory document preparation.
  • Mentor Clinical Operations teams and enhance program performance

Primary Job Requirements :

  • 8 years in pharma / biotech with a scientific BA / BS, I&I experience preferred.
  • Strong knowledge of FDA, ICH GCP guidelines, and experience setting Clinical Operations SOPs.
  • Proven leader adept in fast-paced, start-up environments with excellent teamwork skills.
  • Solid analytical skills, time management, and willingness to travel as needed.
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