New

Clinical Research Program Manager

Mass General Brigham (Enterprise Services)
United States, Massachusetts, Boston
325 Cambridge Street (Show on map)
Aug 11, 2025
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. The role upholds the highest standards of integrity and fiduciary responsibility while delivering exceptional service to the research community and collaborators advancing science and medicine. 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. Bachelor's of Arts or Science degree with mastery of the research process, independent of field of study is required. Master's Degree or PhD preferred. Experience with gene therapy clinical trials is recommended. Minimum 5 years in clinical research setting with experience and knowledge of Good Clinical Practice guidelines and inherited retinal diseases is required. Prior supervisory experience preferred. Strong analytical, communication (written and verbal), quantitative, problem-solving, and organizational skills required. Basic typing and computer skills, including document preparation and Excel spreadsheet capabilities, and medical terminology required. Industry-sponsored and Investigator Initiated clinical trials experience Attention to detail and working under deadline pressure are essential. Possess the ability to interpret information and protocol requirements and initiate appropriate actions. Strong interpersonal and leadership skills with the ability to train, supervise, mentor, and support team members effectively Excellent judgment and ability to make independent, effective decisions in appropriate situations Team building and conflict management skills. Ability to promote collaboration and communication within and beyond the team. SKILLS/ABILITIES/COMPETENCIES Project Supervision: Oversees assigned portfolio of Investigators within designated services, ensuring regulatory and study coordinator support is provided Fosters productive and compliant operations of ongoing research projects. Assists Project Managers in developing, reviewing, and implementing Standard Operating Procedures for approved clinical research protocols. Ensure study assessments, procedures, and enrollment are executed per the study protocol and adhere to all regulatory and ethical policies. Assists with the training and supervision of Project Managers in their duties required for the writing of clinical study protocols and ancillary documents (e.g., ICFs, CRFs, recruitment materials) for review by the Human Studies Committee, sponsor (when applicable), and other regulatory bodies. Works with Project Managers and Study Coordinators to ensure data integrity, including management of any study computer databases. Responsible for ensuring that Study Coordinators maintain up-to-date, accurate, and complete Case Report Forms and other study documents on all study subjects May participate in Investigators' Meetings with Sponsors for new and/or ongoing clinical trials. Training and Oversight: Trains Project Managers and Study Coordinators, and all involved personnel to promote adherence to protocols and regulatory requirements. Keeps abreast of regulatory changes and ensures their team is updated and trained as necessary. Ensures study staff and personnel have fulfilled all required MEE training and study-specific training requirements. Manages project milestones Manage and oversee multi-site trial operations including, Clinical Coordination, Data Coordination and monitoring oversight Oversee adherence of FDA trial requirements Responsible for personnel management and annual performance reviews in concert with the Clinical Research Manager. Financial Responsibilities: Oversees study coordinator responsibilities for patient /subject charges to be debited against clinical study grants and may also assist in coordinating billing or study budgetary tasks with oversight from the Clinical Research Manager. Works with Financial Analyst to ensure budget development is on track for the respective team's studies and to ensure adherence to all Federal regulations and compliance Works with the Agreement Associate to ensure Sponsored agreements are on track and to weigh in on any study-specific details that may affect the contract terms. Ensures that all staff are properly tracking time spent on projects. Provides post-award oversight, including a final monthly review of time tracked by Project Managers and Study Coordinators prior to having the projects charged or the Sponsors invoiced. Compliance: Responsible for ensuring the team follows all regulations, including federal guidelines (HIPAA, OHRP, etc.), for safety, confidentiality, and adherence/compliance of all study documentation. Ensures all staff adhere to DHHS guidelines, including maintenance of required regulatory documents, submitting adverse event reports, annual reviews, and other required reports to the IRB, study sponsor, and other agencies as necessary. Involved in ensuring the Project Managers properly oversee the interactions with Food and Drug Administration (FDA), including applications and other relevant compliance regulations. Maintain active database of all assigned studies within the office, including incoming and closing projects. Working Conditions Category I: Exposure to blood. Universal Precautions mandatory training required for backup support to Study Coordinators. Laptop provided Lifting of 10 to 20 lbs. This is a full-time, onsite role at Mass Eye and Ear Mass General Brigham Incorporated is an Equal Opportunity Employer. By embracing diverse skills, perspectives and ideas, we choose to lead. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment.