Mass General Brigham · 3 weeks ago
Clinical Trial Assistant Project Manager
Somerville-MA
Full-time
Hybrid
Entry, Mid Level
$62K/yr - $91K/yr
2+ years expMass General Brigham is a not-for-profit organization that supports patient care, research, teaching, and community service. The Assistant Project Manager will assist the Project Manager in overseeing and leading clinical research activities, ensuring successful delivery of projects from initiation to close-out while managing scope, schedule, budget, and resources.
Health CareHome Health CareMedical
Responsibilities
Collaborating with project investigators and research sites to ensure targets are met for study start-up, site activation, patient recruitment, and enrollment
Developing study documents including protocol and informed consent forms, study manuals, source documentation templates, recruitment material,s and other study tools
Working closely with Data Management, Systems, and Biostatisticians to assist with the design of case report forms, study portals, and electronic data capture systems
Safety management and reporting to the FDA, Data and Safety Monitoring Boards, Medical Monitors, funding agencies, and other regulatory bodies
Leading cross-functional teams in the timely execution of high-quality clinical research studies, leveraging knowledge, expertise, and risk mitigation
Building effective, high-performance teams via expert communication, decisiveness, and technical expertise
Collecting, reviewing, and approving all required regulatory documents; and working to ensure the study Trial Master File (TMF) is up to date and 'audit ready' throughout the course of the study
Overseeing IND/CTA applications and communication with regulatory agencies (FDA, Health Canada, etc.) for studies with investigator-held INDs/CTAs
Assisting sites with IRB submissions, maintenance of regulatory documents, and responding to study-related questions from sites, vendors, and sponsors in a timely fashion
Scheduling and developing agendas and meeting minutes, in collaboration with the study team, for study-related meetings – both remote and in person, and leading meetings/calls as needed
Tabulating key metrics for progress reports, presentations, and assist in preparing publications
Preparing materials including written summaries for internal and external communication (CT.gov, NEALS website, etc) and grant support (funding updates, progress reports, etc)
Reviewing monitoring plans, tracking, and reviewing trip reports
Working closely with Grants Management on study budget-related questions and invoicing (site payments, vendor contracts, etc)
Working closely with the PI/ Sponsor, assist with the management of vendor activities
Travel to national and international professional meetings as needed
Escalates issues to the Project Manager responsible for assigned projects, as appropriate
Take on additional tasks and responsibilities, as requested
Qualification
Required
A bachelor's degree is required
Previous Industry Clinical Trial experience of 2-3 required
Knowledge of federal regulations relating to the protection of human subjects and good clinical practice guidelines
Attention to detail, excellent organizational and analytical skills
Excellent computer skills, working with Microsoft Office
Team player who can take direction to work independently in an extremely fast-moving, deadline-driven environment, while balancing multiple tasks simultaneously
Preferred
Data Management experience 2-3 years preferred
Background/familiarity with biology or other scientific disciplines is preferred, but not required
Benefits
Comprehensive benefits
Career advancement opportunities
Differentials
Premiums and bonuses as applicable
Recognition programs designed to celebrate your contributions and support your professional growth
Company
Mass General Brigham
Mass General Brigham specializes in providing medical treatments and health diagnostics services.
10001+ employees
H1B Sponsorship
Mass General Brigham has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (77)
2024 (61)
2023 (93)
2022 (70)
2021 (80)
2020 (29)
Funding
Current Stage
Late StageLeadership Team
E
Erin Flanigan
SVP, Human Resources, Community, Specialty Hospital Division
O’Neil A. Britton
Chief Integration Officer, Executive Vice President
Recent News
2026-01-22
2026-01-19
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