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.
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. Identify and proactively resolve issues that may delay the study start-up process. Monitor and address any risks related to site activation, contract negotiation, or regulatory submission. Collaborate with cross-functional teams to implement solutions and mitigate potential risks. Serve as the primary point of contact for internal stakeholders and external partners regarding study activities. Provide regular updates on study start-up progress, timelines, and milestones to department staff, study PIs and senior management. Foster effective communication between clinical teams, sites, and stakeholders to ensure alignment and smooth transitions from start-up to full study execution. Analyze current processes and identify opportunities for efficiency improvements in study activities. Collaborate with leadership to implement process changes and improvements to optimize the study timeline. Performs other related duties, as necessary.
MINIMUM QUALIFICATIONS:
BASIC KNOWLEDGE:
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. This role may require occasional travel to clinical sites, conferences, or company meetings. Ability to work in an office or remote setting. Strong problem-solving skills Detail-oriented Proficiency in Microsoft Office (Excel, Power Point, Outlook, and Word).Highly effective verbal and writing skills required. Ability to foster smooth communications and teamwork among clinical research faculty, fellows and staff as well as external organizations necessary SoCRA (Society of Clinical Research Associates) certified or eligible within 18 months of hire
EXPERIENCE:
Minimum of 5 years of experience in clinical research, with at least 1 year supervisory role.
INDEPENDENT ACTION:
Performs independently within the department policies and practices.
SUPERVISORY RESPONSIBILITY:
Up to 10 FTEs.
Pay Range:
$82,284.80-$135,782.40
Location:
The Miriam Hospital - 164 Summit Ave Providence, Rhode Island 02906
Work Type:
(M-F 8:00am-5:00pm)
Work Shift:
Day
Daily Hours:
8 hours
Driving Required:
No
