Senior Clinical Research Project Manager

Mass General Brigham•Boston, MA

2d•Onsite

About The Position

Manages all recruitment and collection activities for the studies. Functions independently strategizing directly with the PIs. Responsible for the daily execution of principal duties and responsibilities and aspects of project management and administration including operational, budgetary, grant writing, communication, and research subject education components. Also responsible for direct supervision of all research coordinators. The Senior Clinical Research Program Manager is responsible for strategic and operational decision-making across a diverse portfolio of clinical research studies, including industry-sponsored and investigator-initiated, multi-site IDE trials, retrospective chart review studies, and registries. The ideal candidate will have experience and expertise in running investigator-held, multi-site IDE trials. In this role, you will oversee all aspects of study planning and execution, including timelines, budgets, and data management; lead a team of clinical research professionals, which may include research nurses, clinical research coordinators, data analysts, contract research organizations (CROs), and external vendors, to ensure deliverables are met; and collaborate with internal and external stakeholders to ensure studies are conducted efficiently and in compliance with Good Clinical Practice, FDA regulations, and IRB policies. Success in this role requires strong leadership and organizational skills, excellent communication skills, the ability to problem-solve with good judgment, a comprehensive understanding of clinical research processes, and the ability to proactively identify and mitigate risks and resolve operational challenges while driving process improvements.

Requirements

Bachelor's Degree Related Field of Study required
Research Related Experience 5-7 years required
Ability to effectively supervise and train Staff.
Excellent judgement and ability to interpret information and protocol.
Ability to make independent effective decisions.
Aptitude for technical problem solving.
Excellent organizational abilities to formulate and complete rigorous timetables.
Experience and expertise in running investigator-held, multi-site IDE trials.
Strong leadership and organizational skills.
Excellent communication skills.
Ability to problem-solve with good judgment.
Comprehensive understanding of clinical research processes.

Nice To Haves

Master's Degree Related Field of Study preferred
Supervisory Experience 3-5 years preferred

Responsibilities

Manages all recruitment and collection activities for the studies.
Functions independently strategizing directly with the PIs.
Responsible for the daily execution of principal duties and responsibilities and aspects of project management and administration including operational, budgetary, grant writing, communication, and research subject education components.
Responsible for direct supervision of all research coordinators.
Develops detailed protocol documents that meet federal institutional standards.
Ensures study design's compatibility with clinical practices.
Provides critical input as to feasibility of study design and available resources.
Ensures document consistency.
Responsible for developing/managing the clinical trial’s operating and capital budgets.
Oversee all aspects of study planning and execution, including timelines, budgets, and data management.
Lead a team of clinical research professionals, which may include research nurses, clinical research coordinators, data analysts, contract research organizations (CROs), and external vendors, to ensure deliverables are met.
Collaborate with internal and external stakeholders to ensure studies are conducted efficiently and in compliance with Good Clinical Practice, FDA regulations, and IRB policies.
Proactively identify and mitigate risks and resolve operational challenges while driving process improvements.