Clinical Trial Manager, Site Start-Up

Location: Waltham, MA (3 days on-site) Will Consider Remote EAST COAST ONLY

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.