Clinical Trial Program Lead & Start-Up Champion

Lifespan

Providence (RI)

On-site

USD 82,000 - 136,000

Full time

6 days ago

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Job summary

Brown University Health in Providence, RI seeks a Clinical Trial Program Manager to lead initiation and execution of trials, ensuring regulatory compliance and SOP adherence. You will oversee activation from site/PI identification through to start-up and closure, mentoring a team of research staff and coordinating with sponsors, CROs, IRBs, and internal departments.

You will develop budgets and contracts with cross-functional teams, monitor milestones, and implement quality controls while

Qualifications

Strong understanding of clinical trial processes and regulatory standards (ICH-GCP, FDA, EMA).
Experience with study start-up, regulatory submissions, site identification, feasibility, and contracts.
Mentoring and management of study teams including nurses, coordinators, and assistants.
Proficiency in Microsoft Office and ability to work in office or remote settings.

Responsibilities

Oversee and lead activities of clinical trials from site identification to activation and start-up.
Develop and manage timelines, budgets, and regulatory document preparation.
Negotiate and execute study contracts with sites and vendors.
Supervise study nurses, coordinators, and assistants with coaching and performance reviews.
Ensure timely regulatory submissions to IRBs and authorities and monitor compliance.
Maintain quality controls and drive process improvements across studies.
Coordinate with cross-functional teams and external partners for budget alignment.