Senior Clinical Trials Project Manager

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

Summary
The McCance Center for Brain Health at Mass General Hospital/ Mass General Brigham is seeking an experiencedSenior Clinical Trials Project Managerto lead operational execution of a large national Alzheimers 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 Alzheimers 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 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.

Education
Bachelors 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.

Hybrid

399 Revolution Drive

40

Regular

Day (United States of America)

Pay Range

$78936.00 - $128928.80/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 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. We invite you to apply and our Talent Acquisition team will provide an overview of your potential compensation and benefits package.

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 .