Mgr Clinical Trial Program

Rhode Island Hospital; United States; On-site; USD 110,000 - 170,000; Full time

Job summary

Brown University Health seeks a Clinical Trial Program Manager to lead initiation and execution of clinical trials, ensuring compliance with regulatory requirements and SOPs. The role coordinates with sponsors, CROs, IRBs and internal teams throughout the lifecycle of studies.

Responsibilities include activation, budget development, contract negotiations, staff supervision, and quality control while aligning with departmental goals and organizational priorities.

Qualifications

• Experience overseeing initiation and execution of clinical trials.
• Engage with sponsors, CROs, IRBs and internal staff.
• Mentor and supervise a team of research nurses, coordinators and assistants.

Responsibilities

• Lead study site identification, selection, feasibility, SRMC submission, contracts and budgets.
• Manage timelines and budgets; coordinate with clinical research administration and central offices.
• Negotiate and execute site, investigator and vendor contracts; supervise study team; train staff.
• Ensure regulatory documents are submitted to ethics committees and authorities; maintain compliance.

Job description

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

They will oversee the activation process from start to finish, which involves interactions with sponsors, Contract Research Organizations (CROs), External Vendors, Institutional Review Boards (IRBs) and internal staff and institutional external departments.

This process is performed in collaboration with the Principal Investigator, study team members, and other relevant personnel.

They will act as a liaison between different central departments and research teams throughout the lifecycle of the clinical study.

Maintains real-time tracking of the progress and milestones of assigned trials and proactively alerts to potential delays. Responsible for confirming all institutional requirements are met prior to activation implementation.

This role will lead the study process from site/PI identification through to site activation, overall readiness for trial execution, execution, and then closure. As a program manager with supervisory responsibilities, this position will also mentor, train and educate, and supervise a team of research nurses, coordinators, and assistants, ensuring alignment with department goals and organizational priorities. This role is also responsible for implementing quality control measures, evaluating and enhancing processes and systems and collecting and reporting data to internal and external stakeholders.

This role will also be responsible for overseeing the development of study budgets and contracts in collaboration with cross-functional teams.

Brown University Health employees are expected to successfully role model the organization's values of Compassion, Accountability, Respect and Excellence, as these values guide our everyday actions with patients, customers and one another. In addition to our values, all employees are expected to demonstrate the core Success Factors which tell us how we work together and how we get things done. The core Success Factors include: Instill Trust and Value Differences Patient and Community Focus and Collaborate In addition, our leaders will demonstrate an aptitude for: Ensure Accountability and Build Effective Teams Drive Vision and Purpose and Optimize Work Processes By applying core and leadership competencies, leaders help Brown University Health achieve its strategic goals.

PRINCIPAL DUTIES AND RESPONSIBILITIES:

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 onetime and within budget. Responsible for the overall effective operation of protocols which involve the collaboration with clinical research administration, departments, and all central offices. Serves as a liaison between central offices and research staff during the life cycle of a protocol to navigate protocols through the clinical research systems.

Prepares for and attends clinical department meetings for assigned studies. Collaborate with cross-functional teams, including external contractors, to ensure that the development of comprehensive study budgets is in alignment with overall project goals and timelines. Coordinate with external vendors and other departments to address any financial discrepancies or issues related to study budgets.

Lead the development, negotiation, and execution of study-related contracts, including site contracts, investigator agreements, and vendor agreements. Collaborate with legal, procurement, and other internal teams to ensure that contracts meet the company's policies and regulatory requirements. Ensure the timely execution of contracts to allow for efficient site activation and study start-up. Address any issues or concerns raised during the contract negotiation process and resolve them promptly. Supervise a team of study nurses, coordinators, and assistants, ensuring proper resource allocation and timely completion of tasks. Provide ongoing training, coaching, and mentorship to the study team, fostering an environment of continuous improvement. Evaluate team performance, provide regular feedback, and conduct performance appraisals. Ensure timely and accurate submission of regulatory documents to ethics committees, regulatory authorities, and other relevant bodies. Address any regulatory issues that arise during the study, ensuring compliance with regulatory standards and guidelines. Overseeing all IRB submissions and processes.

Stay current with local and international regulations, including but not limited to, ICH-GCP, FDA, EMA, and other regional authorities. Id