Clinical Research Program Manager

Clinical Research Program Manager

The Center for Clinical Research Operations (CCRO) provides support across all Mass. Eye and Ear departments conduct clinical research and are structured to meet the education and quality standards for the conduct of clinical research. The position reports to the Associate Director of the CCRO within Research Management. Responsible for direct oversight of Project Managers and Study Coordinators; Conducts hands-on training of Project Manager and Study Coordinator staff; assists in triaging day-to-day workload, ensures complex regulatory areas are properly handled; and responsible for overseeing operational and financial activities for the designated team. Serves as a resource to Principal Investigators, Grants Administration, Human Research Protection, and Departments across the Hospital. The Clinical Research Program Manager is an active member of the Partners' Central Research Management office and is a primary point of contact for Principal Investigators (PIs). The CCRO Program Manager is committed to identifying and adhering to best practices in clinical research while upholding the highest standards of integrity and fiduciary responsibility. The CCRO Program Manager will proactively address the demands of clinical research by providing exceptional customer service to the research community and collaborators in their pioneering efforts in science and medicine.

Principal Duties and Responsibilities :

Working with their Project Managers and Study Coordinators in supporting the Principal Investigators of assigned service affiliations on the full lifecycle of clinical research : from study design, start-up, implementation, and close-out. Responsible for tracking the status of all scientific and feasibility reviews for their team. Supervises day-to-day activities of team members to provide guidance, input, and problem-solving techniques and to facilitate growth and professional development. Reporting to the Director of the CCRO and the IRD Service for the oversight and management of all IRD clinical trials, the Clinical Research Program Manager provides direct oversight of Project Managers and Study Coordinators within the Inherited Retinal Disease (IRD) Clinic, with a focus on complex, high-risk gene therapy trials. This role includes hands-on training of staff, triaging daily workload, and ensuring compliance with intricate regulatory requirements. The Program Manager is responsible for the operational and financial management of the assigned team and serves as a key resource to Principal Investigators (PIs), Grants Administration, Human Research Protection, and departments across the hospital. As an active member of Mass General Brigham, the Program Manager serves as a primary point of contact for PIs and is committed to identifying and implementing best practices in clinical research.

Key Responsibilities :

• Oversee multiple clinical research studies, including high-risk gene therapy trials.
• Hire, train, and supervise Clinical Research Coordinators and Project Managers. Serve as the primary liaison with sponsors, IRBs, core laboratories, site PIs, and study staff.
• Coordinate trial initiation, patient recruitment, and expedite study start-up and approval processes.
• Develop and maintain standard operating procedures (SOPs) for assigned projects.
• Design and implement advertising strategies to support recruitment efforts.
• Manage study budgets and subcontracts with affiliated institutions.
• Supervise daily operations of all study staff.
• Write and maintain operations manuals and case report forms.
• Participate in policy and procedure development for clinical studies.
• Coordinate multi-center trials in collaboration with NIH, FDA, and private foundations.
• Report study progress at investigator meetings.

Qualifications :

Skills / Abilities / Competencies :

Project Supervision :

Training and Oversight :

Financial Responsibilities :

Compliance :

Working Conditions :

Remote Type : Onsite

Work Location : 325 Cambridge Street

Scheduled Weekly Hours : 40

Employee Type : Regular

Work Shift : Day (United States of America)

Pay Range : $62,004.80 - $90,7