Senior Clinical Trials Project Manager

Mass General Brigham•Somerville, MA

6d•$78,936 - $128,929•Hybrid

About The Position

The McCance Center for Brain Health at Mass General Hospital/ Mass General Brigham is seeking an experienced Senior Clinical Trials Project Manager to lead operational execution of a large, national Alzheimer’s disease prevention platform. The Sr Clinical Trials PM will oversee overall project management activities of multi-center clinical trials led by the McCance Center. This high-impact, multi-institutional effort is led by Drs. Gene Bowman and Rudolph Tanzi and executed through the McCance Center for Brain Health, and collaborating groups internally at MGB as well as externally. The Senior Clinical Trials Project Manager will be the key liaison with stakeholders including funding agencies, central vendors, study staff and trial site leads. The Senior Clinical Trial Project Manager will serve as the central operational lead responsible for translating scientific strategy into a coordinated national trial program. This role requires deep expertise in multicenter interventional trial management, project management tools and techniques, cross-functional leadership, milestone-driven execution, and high-level coordination across academic, clinical, and federal funding environments. The Senior Clinical Trial Project Manager will lead the planning, startup, implementation, and performance management for national clinical trials focused on Alzheimer’s disease prevention, including multi-site studies investigating natural product combinations and development of a large platform trial infrastructure. Working closely with Dr. Bowman, Dr. Tanzi, collaborating leadership at MGB and externally, including partner sites across the country, this individual will ensure that the studies are delivered on time, on budget, and in compliance with protocol, regulatory, contractual, and sponsor requirements. Responsible for all aspects of project administration and coordination of multiple clinical trials including multi-center trials. Duties include the review of all proposals, budgets, and contracts and tracking of all milestones and timelines. The development of study related documents, completion of data management functions, and reporting of safety and endpoints to the study sponsor and IRB. For multi-site trials, the overall direction of the clinical sites for protocol adherence is under the direction. Accountable for assuring that the project team that he/she leads meets all deadlines and is also required to maintain a close effectual working relationship with Sponsors, Study Coordinators, and Principal Investigators. Travel may be required to meetings with collaborators and sites across the United States. Meetings may occur outside standard hours to accommodate nation-wide collaborators and sites. This is a hybrid position requiring at least three days/week onsite at the MGB Assembly Row campus.

Requirements

Bachelor's Degree Related Field of Study required
Clinical Research Experience 3-5 years required
Must be able to prioritize multiple, competing tasks with excellent organizational skills.
Strong interpersonal and leadership skills with ability to train, supervise, mentor and support team members effectively.
Excellent judgment and ability to make independent effective decisions in appropriate situations.
Team building and conflict management skills.
Ability to promote collaboration and communication within and beyond the team.

Responsibilities

Coordinate the development of investigator-initiated and industry sponsored project documents and timelines and manage any changes, including future timeline changes that may result from changes in scope, delays in schedule or resource constraints.
Is responsible for all regulatory maintenance for assigned clinical research and trial projects including IRB submissions, biosafety committee submissions, FDA submissions and reporting, funding agency reporting, clinicaltrials.gov record maintenance, and other related tasks on assigned projects.
Monitors and manages sub-sites on multi-center clinical research projects including facilitating regular sub-site status meetings, overseeing sub-site data collection and quality, and collecting sub-site regulatory documentation and ensuring compliance.
Develop and finalize complete project plans with formalized project milestones and deliverables.
Facilitate and maintain records of all internal and external communication relevant to assigned clinical trials.
Responsible for Project Operating Planning Manual development.
Present and lead presentations at site initiations or trial kick off meetings.