[Hiring] Clinical Trial Program Manager @Brown Medicine

Role Description

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 that all activities are conducted in compliance with regulatory requirements, company policies, and standard operating procedures (SOPs).

• Oversee the activation process from start to finish, involving interactions with sponsors, Contract Research Organizations (CROs), External Vendors, Institutional Review Boards (IRBs), and internal staff.
• Act as a liaison between different central departments and research teams throughout the lifecycle of the clinical study.
• Maintain real-time tracking of the progress and milestones of assigned trials and proactively alert to potential delays.
• Confirm all institutional requirements are met prior to activation implementation.
• Lead the study process from site/PI identification through to site activation, overall readiness for trial execution, execution, and closure.
• Mentor, train, educate, and supervise a team of research nurses, coordinators, and assistants.
• Implement quality control measures, evaluate and enhance processes and systems, and collect and report data to internal and external stakeholders.
• Oversee the development of study budgets and contracts in collaboration with cross-functional teams.

Qualifications

• 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 (e.g., ICH-GCP, FDA, EMA).
• Experience with study start-up activities, including regulatory submissions, site identification, feasibility assessments, and contract negotiation.
• Strong background in contract negotiation and execution, particularly in clinical trial settings.
• Exceptional mentoring and team management skills.
• Excellent organizational, project management, and communication skills.
• Ability to manage multiple priorities and projects in a fast-paced environment.
• Proficient in using clinical trial management systems (CTMS) and other clinical trial-related software.
• Prior experience with study start-up, either within an institutional department, in a CRO or sponsor setting.
• Strong problem-solving skills and detail-oriented.
• Proficiency in Microsoft Office (Excel, PowerPoint, Outlook, and Word).
• Highly effective verbal and writing skills required.
• SoCRA (Society of Clinical Research Associates) certified or eligible within 18 months of hire.

Requirements

• Minimum of 5 years of experience in clinical research, with at least 1 year in a supervisory role.
• Ability to work in an office or remote setting.
• This role may require occasional travel to clinical sites, conferences, or company meetings.

Benefits

• Pay Range: $82,284.80-$135,782.40

Company Description

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