Brown University Health · 10 hours ago
Clinical Trials Program Manager
Providence, RI
Full-time
Hybrid
Mid, Senior Level
$82K/yr - $136K/yr
5+ years expBrown University Health is seeking a Clinical Trials Program Manager to lead and oversee the initiation and execution of clinical trials. The role involves ensuring compliance with regulatory requirements, managing study activities, and supervising a team of research staff to ensure successful trial execution.
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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
Qualification
Required
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
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
Minimum of 5 years of experience in clinical research, with at least 1 year supervisory role
Company
Brown University Health
Brown University Health provides an integrated academic health system offering hospital services, outpatient care and clinical education.
10001+ employees
Funding
Current Stage
Late StageRecent News
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