Clinical Trials Program Manager

Overview

Summary:

Reporting to the Divisional Research Director or Chief at Brown University Health, the Clinical Trial Program Manager will lead and oversee the initiation and execution of clinical trials, ensuring compliance with regulatory requirements, company policies, and standard operating procedures (SOPs). They will oversee the activation process from start to finish, collaborating with sponsors, CROs, external vendors, IRBs, and internal staff.

They will act as a liaison among central departments and research teams, maintain real‑time tracking of progress and milestones, and proactively address potential delays. The role includes studying budgets, contracts, and quality control measures, while mentoring a team of nurses, coordinators, and assistants.

• Oversee and lead trial activities, including site identification, selection, feasibility assessments, SRMC submission, and regulatory document preparation.
• Develop and manage study timelines, ensuring completion on time and within budget.
• Serve as liaison between central offices and research staff throughout a protocol’s lifecycle.
• Collaborate with cross‑functional teams to align study budgets with project goals.
• Lead development, negotiation, and execution of site, investigator, and vendor contracts; coordinate with legal, procurement, and other internal teams.
• Supervise up to 10 staff members, providing training, coaching, and performance evaluations.
• Ensure timely and accurate submission of regulatory documents to ethics committees, regulatory authorities, and relevant bodies.
• Monitor risks related to site activation, contract negotiation, and regulatory submission, implementing mitigation strategies.
• Act as primary point of contact for internal stakeholders and external partners regarding study activities, providing regular updates on progress and milestones.
• Analyze processes to identify opportunities for efficiency improvements and collaborate with leadership to implement changes.
• Perform additional related duties as necessary.

• Bachelor’s degree in Life Sciences, Nursing, Pharmacy, or related field (advanced degree preferred).
• Strong knowledge of clinical trial processes, regulations, and industry standards (e.g., ICH‑GCP, FDA, EMA).
• Experience with study start‑up activities, including regulatory submissions, site identification, feasibility assessments, and contract negotiation.
• Proficiency in CTMS and related clinical trial software.
• Minimum of 5 years clinical research experience, with at least 1 year in a supervisory role.
• Excellent organizational, project management, and communication skills; ability to manage multiple priorities in a fast‑paced environment.
• Strong problem‑solving and detail‑oriented mindset.
• Proficiency in Microsoft Office (Excel, PowerPoint, Outlook, Word).
• Effective verbal and written communication skills, fostering smooth teamwork among clinical research faculty, fellows, staff, and external partners.
• SoCRA certified or eligible within 18 months of hire.

Pay Range: $82,284.80 - $

Brown University Health is committed to providing equal employment opportunities and maintaining a work environment free from all forms of unlawful discrimination and harassment.

The Miriam Hospital - 164 Summit Ave, Providence, Rhode Island 02906

Work Type: M-F 8:30am – 5pm

Shift: Day
Daily

Hours:

8 hours
Driving

Required:

No