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Clinical Trial Manager

2 months ago

waltham, United States GQR Full time

Clinical Trial Manager, Site Start-Up

Location: Waltham, MA (3 days on-site)

Department: Clinical Operations


About the Role

Our client, an innovative biotech company, is seeking a skilled Clinical Trial Manager, Site Start-Up to support their rapidly expanding clinical programs. Reporting to the Director of Clinical Operations, the successful candidate will be responsible for overseeing the entire site start-up process across multiple studies. This is a key role, offering the opportunity to drive clinical trial success by working closely with cross-functional teams and external partners to ensure the timely initiation and activation of clinical sites.


Key Responsibilities:

  • Lead and manage site initiation and activation activities.
  • Develop and execute Site Initiation Management Plans.
  • Manage regulatory and ethics committee submissions.
  • Oversee essential document preparation and informed consent processes.
  • Coordinate contract and budget negotiations.
  • Act as the escalation point for start-up issues with CROs and site teams.


Requirements:

  • Bachelor’s degree in Life Sciences or a related field (advanced degree preferred).
  • 5+ years of clinical operations experience, with a focus on trial start-up.
  • Strong vendor management skills and experience working with both sponsors and CROs.
  • Ability to juggle multiple studies and drive results in a fast-paced environment.


This is a unique opportunity for a driven and adaptable individual who thrives in a fast-paced, early-stage clinical environment. Candidates must be willing to work on-site three days a week.