Senior Clinical Trials Startup & Program Lead

Brown University Health; Providence (RI); In loco; USD 82.000 - 136.000; Tempo pieno

Descrizione del lavoro

Brown University Health seeks an experienced Clinical Trial Program Manager to lead initiation and execution of clinical trials, ensuring regulatory compliance and SOP adherence. You will manage site activation, budgets, contracts, and vendor interactions across IRBs and internal partners.

The role includes mentoring a team of research nurses, coordinators and assistants, optimizing processes, and reporting progress to stakeholders. Travel to clinical sites may be required.

Competenze

• Bachelor’s degree in Life Sciences, Nursing, Pharmacy, or a related field (advanced degree preferred).
• Strong understanding of clinical trial processes, regulations, and industry standards (ICH-GCP, FDA, EMA).
• Experience with study start-up activities, including regulatory submissions, site identification, feasibility assessments, and contract negotiation.

Mansioni

• Oversee and lead activities of clinical trials, including study site identification, selection, feasibility assessments, SRMC submission and outcome, contracts, budget, IRB submission and regulatory document preparation.
• Develop and manage timelines, ensuring study activities are completed on time and within budget.
• Lead the development, negotiation, and execution of study-related contracts, including site contracts, investigator agreements, and vendor agreements.

Conoscenze

Project management

Communication

Mentoring

Team management

CTMS

Microsoft Office

Formazione

Bachelor’s degree in Life Sciences, Nursing, Pharmacy, or related field

Advanced degree preferred

Strumenti

CTMS

Microsoft Office

Descrizione del lavoro

Brown University Health seeks an experienced Clinical Trial Program Manager to lead initiation and execution of clinical trials, ensuring regulatory compliance and SOP adherence. You will manage site activation, budgets, contracts, and vendor interactions across IRBs and internal partners.

The role includes mentoring a team of research nurses, coordinators and assistants, optimizing processes, and reporting progress to stakeholders. Travel to clinical sites may be required.