Senior Clinical Research Program Manager

Mass General Brigham•Boston, MA

4d•Hybrid

About The Position

This position will have dual reporting to the AMC Division of Allergy and Clinical Immunology (ACI) Division Director and the Manager of Finance & Research Administration and He/She will work closely with the Director of Clinical Research. The Senior Clinical Research Program/Project Manager plays a key role in coordinating the clinical research program administration. This includes overseeing research protocol management; supervising and training staff; supporting principal investigators with strategic planning, team organization, and grant preparation; coordinating materials transfers and data management/sharing; managing budgets and financial planning; and supporting conference and travel planning. The position manages key administrative HR functions such as hiring (in coordination with PIs), onboarding, and this role will evaluate and conduct the education and training program for the clinical research coordinators. The Senior clinical research program manager will be responsible for the day-to-day supervision of clinical research coordinators, including performance support and annual performance evaluations (pay changes, promotions, renewals). The manager also helps define study responsibilities and level of effort, oversees time tracking and project communication, and supports clinical trial billing activities. Serves as a resource to ACI MGB coordinators and Principal Investigators.

Requirements

5-7 years of research-related experience 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.

Nice To Haves

3-5 years of supervisory experience preferred.

Responsibilities

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.
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.
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.
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.
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.
Manage data/materials transfer agreements between collaborating institutions; develop data collection systems (CRFs) and perform rigorous validation and quality control.
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.
Manage all protocol inquiries, participant correspondence, and regular reporting to Principal Investigators regarding trial progress.
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.