Clinical Trials Project Manager Senior
Mass General Brigham relies on a wide range of professionals to advance our mission as a not-for-profit supporting patient care, research, teaching, and community service. We believe that high-performing teams drive groundbreaking medical discoveries and invite all applicants to join us.
About the role
The Neurological Clinical Research Institute (NCRI) at Massachusetts General Hospital (MGH) is a premier Academic Clinical Research Organization (CRO) managing clinical trials in neurological disorders. Reporting to the Director of Research Operations, the Senior Project Manager will oversee project management activities for assigned multi-center clinical research studies, providing guidance to investigators and study teams, and serving as the key liaison with sponsors, funding agencies, vendors, and staff to ensure smooth trial operations.
Responsibilities
- Oversee all aspects of study start-up, conduct, and close-out for a portfolio of multi-center and single-center clinical trials.
- Participate in the design and implementation of new proposals and projects, leveraging knowledge of FDA, OHRP regulations, GCP, and NIH guidelines.
- Plan and conduct Project Management team meetings.
- Directly manage and mentor staff, including developing goals, performance evaluations, and HR-related functions such as hiring and corrective action.
- Assist in developing and maintaining best practice guidelines, study tool templates, and Standard Operating Procedures (SOPs).
- Collaborate with the Director to set priorities and structure for the Project Management team.
- Lead cross-functional teams to ensure timely execution of high-quality clinical research projects, leveraging expertise and risk mitigation strategies.
- Build effective, high-performing teams through communication, decisiveness, and technical expertise.
- Manage formal communications with regulatory agencies (FDA, Health Canada), funding agencies (NIH, industry sponsors, foundations), and safety monitoring boards.
- Travel to national and international professional meetings as needed.
- Initiate process improvement projects to enhance clinical trial operations across a portfolio of studies.
- Lead budget development and monitor study expenditures in collaboration with the grants management group.
- Attend, present, and participate in professional meetings and trainings.
- Troubleshoot study-related issues and escalate as appropriate.
- Take on additional tasks and responsibilities as requested.
Qualifications
- Bachelor’s degree in a related field of study (required; experience cannot substitute for degree).
- 3–5 years of clinical research experience (required).
- 7–10 years of clinical research experience (preferred).
- Comprehensive understanding of GCP, ICH guidelines, and relevant FDA regulations, with the ability to implement and advise on these standards.
- Knowledge of data management concepts and ability to ensure data quality.
- Familiarity with the role of study monitors/CRAs and ability to supervise monitoring teams.
- Understanding of grant administration, contracts, and finance roles in study teams to manage budgets and site payments effectively.
Skills
- Ability to prioritize multiple, competing tasks with excellent organizational skills.
- Strong interpersonal and leadership skills, including the ability to train, supervise, mentor, and support team members.
- Excellent judgment and ability to make independent, effective decisions.
- Team-building and conflict management skills.
- Ability to promote collaboration and communication within and beyond the team.
Additional Details
This is a hybrid role based at 123 Main Street, with scheduled weekly hours of 40.
Pay
Annual pay range: $78,936.00 – $128,928.80 (Grade 8). Offers will reflect skills, relevant experience, education, certifications, and other factors. Total compensation includes competitive base pay, comprehensive benefits, career advancement opportunities, differentials, premiums, bonuses (as applicable), and recognition programs.