Clinical Research Program/Project Manager

Mass General BrighamBoston, MA
$63,253 - $102,596Onsite

About The Position

The Clinical Research Program/Project Manager serves as the primary operational and administrative lead for the laboratory’s clinical projects within the Department of Neuroimmunology. This role is responsible for the comprehensive management, coordination, and oversight of investigator-initiated, industry-sponsored, and federally funded clinical research studies, as well as related programmatic activities. Working directly with the Principal Investigator, the Clinical Research Program/Project Manager oversees all phases of clinical research operations, including study startup, regulatory submissions, project execution, staff supervision, budget oversight, sponsor coordination, data management, and reporting. The position plays a central leadership role in ensuring that all research activities are conducted efficiently, ethically, and in compliance with institutional policies and federal regulations. The Clinical Research Program/Project Manager also supports strategic growth of the research program through process improvement initiatives, grant development support, operational planning, and mentorship of research staff and trainees. 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.

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.

Benefits

  • comprehensive benefits
  • career advancement opportunities
  • differentials
  • premiums
  • bonuses
  • recognition programs
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