Clinical Trial Program Lead & Start-Up Champion

Lifespan; Providence (RI); On-site; USD 82,000 - 136,000; Full time

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.

Skills

Clinical trial management

Regulatory compliance

Team leadership

CTMS

Vendor management

Education

Bachelor's degree in Life Sciences / Nursing / Pharmacy or related field

Advanced degree preferred

SoCRA certification or eligible within 18 months

Tools

CTMS

Job description

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