Clinical Trial Manager

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.