Senior Clinical Trials Project Manager

1200 The General Hospital Corporation; Somerville (MA); Hybrid; USD 77,000 - 129,000; Full time

Job summary

Mass General Brigham is seeking an experienced Senior Clinical Trials Project Manager to lead the operational execution of a national Alzheimer's disease prevention platform. You will oversee multi-center clinical trials, liaising with funding agencies, vendors, and trial sites to ensure on-time, on-budget delivery and protocol compliance.

In this role, you will drive planning, startup, implementation, and performance management for a national trial program, coordinating with leaders and

Qualifications

• Bachelor's Degree in Related Field 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.

Responsibilities

• Coordinate the development of investigator-initiated and industry sponsored project documents and timelines and manage changes.
• Regulatory maintenance for IRB submissions, biosafety committee submissions, FDA submissions and reporting.
• Monitors and manages sub-sites on multi-center clinical research projects and ensures regulatory compliance.
• Develop and finalize complete project plans with formal milestones and deliverables.
• Present and lead presentations at site initiations or trial kick offs.

Skills

Prioritization

Leadership

Team coordination

Communication

Decision making

Education

Bachelor's Degree in Related Field

Job description

Site: The General Hospital Corporation 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

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.

Essential Functions

• 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.

Qualifications

• Education Bachelor's Degree Related Field of Study required
• Can this role accept experience in lieu of a degree? No
• Experience Clinical Research Experience 3-5 years required
• Knowledge, Skills and Abilities - 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.

Additional Job Details

• Remote Type Hybrid
• Work Location 399 Revolution Drive
• Scheduled Weekly Hours 40
• Employee Type Regular
• Work Shift Day (United States of America)
• Pay Range $78,936.00 - $128,928.80/Annual
• Grade 8

At Mass General Brigham, we believe in recognizing and rewarding the unique value each team member brings to our organization. Our approach to determining base pay is comprehensive, and any offer extended will take into account your skills, relevant experience if applicable, education, certifications and other essential factors. The base pay information provided offers an estimate based on the minimum job qualifications; however, it does not encompass all elements contributing to your total compensation package. In addition to competitive base pay, we offer comprehensive benefits, career advancement opportunities, differentials, premiums and bonuses as applicable and recognition programs designed to celebrate your contributions and support your professional growth.

EEO Statement: 1200 The General Hospital Corporation is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. To ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veterans Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact Human Resources at (857)-282-7642.

Mass General Brigham Competency Framework At Mass General Brigham, our competency framework defines what effective leadership "looks like" by specifying which behaviors are most critical for successful performance at each job level. The framework is comprised of ten competencies (half People-Focused, half Performance-Focused) and are defined by observable and measurable skills and behaviors that contribute to workplace effectiveness and career success. These competencies are used to evaluate performance, make hiring decisions, identify development needs, mobilize employees across our system, and establish a strong talent pipeline.

Combat disease. Hold a hand. Help people. Impact the world. Mass General Brigham is a passionate, welcoming community where minds meet caring hearts. Come be a part of the world's most powerful force in medicine, where every role is important in changing lives. Are you ready? Our history includes New England hospitals founded over 200 years ago, some of the first and most prestigious hospitals in the world. Built on the legacy of two leading academic medical centers, we're more than a system—we're leaders in the practice of medicine. Mass General Brigham is committed to serving the community. We are dedicated to enhancing patient care, teaching and research, and taking a leadership role as an integrated health care system. We recognize that increasing value and continuously improving quality are essential to maintaining excellence.