Clinical Trials Program Manager

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Job ID: JR-104932
Entity: The Miriam Hospital
Location Name: The Miriam Hospital
City, State: Providence, RI
Work Type: FULL TIME
Hours Per Week: 40
Shift: Day
Posted Date: 1/27/2026

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
Collaborate

In addition, our leaders will demonstrate an aptitude for:

Ensure Accountability
Build Effective Teams
Drive Vision and Purpose
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 on time and within budget. Responsible for the overall effective operation of protocols which involve 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.

Prepare for and attend 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. Oversee 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. Perform 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, PowerPoint, 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 in a 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

EEO Statement

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