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.
