Clinical Research Project Manager

Mass General Brigham•Boston, MA

11h•Hybrid

About The Position

Responsible for the management of multiple clinical research studies and the direct hiring and supervision of Clinical Research Coordinators. Serves as the key liaison with the sponsor, IRB, core laboratories, site P.I.'s, as well as all levels of study staff. Will also coordinate trial initiation, patient recruitment, and expedite project approval and study start-up time. Responsibilities also include participation in developing and maintaining standard operating procedures for the projects, developing advertising strategies to support recruitment activities, oversee budget management and subcontracts with associated institutions. The Mass General Brigham Amyloidosis Program is a multidisciplinary clinical and research program focused on improving the diagnosis, characterization, and treatment of systemic and cardiac amyloidosis. Our research team at the Brigham and Women's Hospital includes physician investigators, medical imaging physicists, research fellows (fully trained cardiologists), a data analyst, and ten research assistants (who recruit participants for our research projects). We conduct a diverse portfolio of industry-sponsored, investigator-initiated, foundation-funded, and NIH-funded studies, including therapeutic clinical trials, imaging studies, biomarker and biobanking protocols, and multicenter national and international research collaborations. Several studies involve regulatory oversight, including IND-regulated investigations, and leverage advanced cardiovascular imaging modalities such as echocardiography, cardiac MRI, and nuclear imaging. We envision this project manager serving as the operational lead for our research portfolio, overseeing study startup, regulatory compliance, budget and contract coordination, monitoring and audit readiness, and day-to-day project management across multiple active protocols. The individual would supervise and support research staff (the large team of research assistants), coordinate activities among investigators, sponsors, CROs, and institutional offices, and help ensure efficient execution of studies from initiation through closeout. The role will be central to maintaining a high-performing research infrastructure and supporting continued growth of the Amyloidosis Program across MGB.

Requirements

Bachelor's Degree Related Field of Study required
Research Related Experience 5-7 years required
Ability to make independent effective decisions.
Strong organizational and communication Skills.
Ability to effectively supervise and train Staff.
Strong database management and computer skills.
Demonstrated analytical skills to problem solve effectively.
Must possess strong budget management skills.

Nice To Haves

Master's Degree Related Field of Study preferred
Supervisory Experience 1-2 years preferred

Responsibilities

Supervises operations of all study staff.
Writes operations manuals.
Participates in the formulation of policies and procedures for the study.
Prepares Case Report Forms.
Coordinates multi-center trials with NIH, FDA and Private foundations.
Reports study progress at investigators' meetings.
Overseeing study startup, regulatory compliance, budget and contract coordination, monitoring and audit readiness, and day-to-day project management across multiple active protocols.
Supervise and support research staff (the large team of research assistants).
Coordinate activities among investigators, sponsors, CROs, and institutional offices.
Help ensure efficient execution of studies from initiation through closeout.