Associate Director Clinical Operations

Salary $195,000
LocationCambridge, Massachusetts
Employment type Permanent
Discipline
Life Sciences

Job description

Associate Director, Clinical Operations

Cambridge, MA
Clinical Development /

A growing biotech organization is seeking a resourceful and collaborative Associate Director to join its Clinical Operations team and support programs across a diverse portfolio of programs revolutionizing the field of organ transplantation. This role will work cross-functionally with teams in Regulatory, Quality, Manufacturing, and Development to drive clinical programs forward. The Associate Director will be responsible for the day-to-day management of clinical studies, vendors, and sites in alignment with organizational goals. Success in this role requires strong attention to detail, excellent communication skills, and a collaborative mindset.

Primary Responsibilities

  • Oversee all aspects of clinical trials, including vendor setup and management, CRO oversight, timelines, and budgets.
  • Lead site selection, qualification discussions, kick-off meetings, and study team meetings.
  • Conduct study risk assessments and implement mitigation and contingency plans.
  • Monitor potential risks and collaborate with cross-functional teams to address them proactively.
  • Prepare and review clinical study documentation such as protocols, informed consent forms, study plans, CRFs, and clinical study reports.
  • Maintain clear communication with stakeholders regarding study status, metrics, and timelines.
  • Ensure studies are conducted in accordance with SOPs and ICH-GCP guidelines.
  • Serve as the primary point of contact for CROs, vendors, and clinical sites.
  • Set up and maintain the Trial Master File (TMF), including periodic reviews.
  • Support audit readiness and resolution of audit findings.

Basic Qualifications

  • Bachelor’s degree required.
  • 10+ years of experience in life sciences or a medically related field, including 7+ years in clinical research within biotech, pharma, or CRO settings.
  • Proven experience managing external vendors (e.g., CROs, central labs).
  • Strong organizational and interpersonal skills with a high attention to detail.
  • Working knowledge of Good Clinical Practices (GCP) and relevant regulatory requirements.
  • Willingness to travel up to 10%.
  • Background in life sciences or medicine preferred.
  • Previous experience as a Clinical Research Associate (CRA) is a plus.