Senior Clinical Research Project Manager
Mass General Brigham
Summary
Manages all recruitment and collection activities for the studies. Functions independently strategizing directly with the PIs. Responsible for the daily execution of principal duties and responsibilities and aspects of project management and administration including operational, budgetary, grant writing, communication, and research subject education components. Also responsible for direct supervision of all research coordinators.
Job description
Job Summary
Manages all recruitment and collection activities for the studies. Functions independently strategizing directly with the PIs. Responsible for the daily execution of principal duties and responsibilities and aspects of project management and administration including operational, budgetary, grant writing, communication, and research subject education components. Also responsible for direct supervision of all research coordinators.
Essential Functions
- Develops detailed protocol documents that meet federal institutional standards.
- Ensures study design's compatibility with clinical practices.
- Provides critical input as to feasibility of study design and available resources.
- Ensures document consistency.
- Responsible for developing/managing the clinical trial's operating and capital budgets.
Additional Job Details
The Senior Clinical Research Program Manager is responsible for strategic and operational decision-making across a diverse portfolio of clinical research studies, including industry-sponsored and investigator-initiated, multi-site IDE trials, retrospective chart review studies, and registries. The ideal candidate will have experience and expertise in running investigator-held, multi-site IDE trials. In this role, you will oversee all aspects of study planning and execution, including timelines, budgets, and data management; lead a team of clinical research professionals, which may include research nurses, clinical research coordinators, data analysts, contract research organizations (CROs), and external vendors, to ensure deliverables are met; and collaborate with internal and external stakeholders to ensure studies are conducted efficiently and in compliance with Good Clinical Practice, FDA regulations, and IRB policies. Success in this role requires strong leadership and organizational skills, excellent communication skills, the ability to problem-solve with good judgment, a comprehensive understanding of clinical research processes, and the ability to proactively identify and mitigate risks and resolve operational challenges while driving process improvements.
Requirements
- Bachelor's Degree in Related Field of Study required
- Master's Degree in Related Field of Study preferred
- Research Related Experience 5-7 years required
- Supervisory Experience 3-5 years preferred
- Ability to effectively supervise and train Staff
- Excellent judgement and ability to interpret information and protocol
- Ability to make independent effective decisions
- Aptitude for technical problem solving
- Excellent organizational abilities to formulate and complete rigorous timetables
Benefits
- Comprehensive benefits package
- Career advancement opportunities
- Recognition programs
- Differentials, premiums and bonuses
Company overview
Mass General Brigham is one of the largest integrated healthcare delivery systems in the United States, formed through the merger of Massachusetts General Hospital and Brigham and Women's Hospital. Based in Boston, Massachusetts, this academic medical center system operates multiple hospitals, specialty facilities, and community health centers throughout New England. The organization is renowned for its world-class patient care, cutting-edge medical research, and comprehensive medical education programs. As a teaching affiliate of Harvard Medical School, Mass General Brigham trains the next generation of healthcare professionals while advancing medical science through groundbreaking research initiatives. The system provides a full continuum of healthcare services, from primary care and preventive medicine to complex specialty treatments and emergency services. With a focus on innovation and patient-centered care, Mass General Brigham consistently ranks among the top hospital systems in the nation for clinical excellence and research output.