Senior Clinical Research Program Manager

Mass General Brigham relies on a wide range of professionals, including doctors, nurses, business people, tech experts, researchers, and systems analysts to advance our mission. As a not-for-profit, we support patient care, research, teaching, and community service, striving to provide exceptional care. We believe that high-performing teams drive groundbreaking medical discoveries and invite all applicants to join us and experience what it means to be part of Mass General Brigham.

Job Summary

KEY ROLES AND RESPONSIBILITIES:

Project Management (Essential Functions)

• Project Lifecycle & Team Leadership: Oversee all administrative aspects of multiple active and pending Clinical research projects from inception to completion; define scope, goals, deliverables, and timelines while delegating tasks and managing study coordinators.
• Operational Oversight: Drive Clinical research trial projects by developing protocols with PI and coordinators, organizing meetings, and ensuring adherence to research protocols, data agreements, and quality standards across the portfolio.
• Financial & Resource Management: Execute and reconcile financial transactions (Check Requests, eBuy, Advarra) and industry-sponsored payments using MGB OnCore and Insight; oversee procurement and maintenance of study equipment.
• Regulatory & IRB Compliance: Manage Central and local IRB submissions, continuing reviews, protocol expiration dates, and timely reporting to prevent lapses; maintain expert knowledge of FDA/NIH guidelines, IND/IDE applications, and ClinicalTrials.gov requirements.
• Clinical Subject Management: Develop recruitment strategies, screen participants for suitability, and serve as the primary liaison between patients, families, and PIs; perform clinical tasks including phlebotomy and ECGs as required.
• Data Integrity & Coordination: Manage data/materials transfer agreements between collaborating institutions; develop data collection systems (CRFs) and perform rigorous validation and quality control.
• Audit & Site Readiness: Facilitate study monitoring and auditing visits with sponsors and third-party auditors; provide guidance to research teams on federal/state compliance and Good Clinical Practice (GCP).  Appropriately documents and completes study close-outs and fund inactivation.
• Communications: Manage all protocol inquiries, participant correspondence, and regular reporting to Principal Investigators regarding trial progress.

Other Duties & Responsibilities:

Manage multi-site clinical studies, including site identification and feasibility, compliance assessment, and support for site contracting and agreement execution. Train site staff on study protocols and use of web-based data collection systems. Develop standard operating procedures and collaborate with investigators, clinicians, software developers, and laboratory personnel. Provide human research education at MGB institutions to groups of varying sizes, as assigned.

Can this role accept experience in lieu of a degree?
No

Experience
Research Related Experience 5-7 years required and Supervisory Experience 3-5 years preferred

SKILLS/ ABILITIES/ COMPETENCIES REQUIRED:

• Thorough knowledge of federal and institutional policies governing clinical research
• A broad understanding of Hospital practices and policies to assess and direct a wide range of practice issues
• Knowledge of clinical research protocols
• Strong interpersonal, communication, and organizational skills.
• Proficiency in Microsoft Office and related software; ability to learn new systems quickly. Oncore and clinical trials.gov
• Ability to handle confidential information and maintain professionalism.
• Detail-oriented, proactive, and adaptable to changing priorities.
• Ability to work independently and as part of a team.

Pay Range

Grade

Mass General Brigham Competency Framework