Clinical Research Program Manager

Broad Institute•Cambridge, MA

About The Position

The Clinical Research Program Manager leads clinical research operations for a multidisciplinary program investigating inflammatory and autoimmune diseases. The program brings together investigators, clinicians, and research teams at the Broad Institute of MIT and Harvard and Massachusetts General Hospital. The role contributes to the Broad Institute’s GaMBiT Initiative, which aims to understand how genetic factors increase disease risk and translate genetic discoveries into therapeutics. The position works closely with colleagues at Massachusetts General Hospital and across both locations as part of a highly collaborative team. The program seeks to understand disease development and progression, differences in patient responses to therapy, and how research findings can lead to improved interventions. It deeply characterizes patients and integrates clinical information with molecular and cellular measurements to identify disease mechanisms, biomarkers, and opportunities for prevention and treatment. The manager connects patient-oriented research at Massachusetts General Hospital with genomic, immunologic, microbiome, metabolomic, single-cell, spatial, and computational research. Studies include prospective clinical cohorts, detailed clinical phenotyping, and collection of blood, tissue, stool, and other biospecimens for molecular analysis. At the interface of clinical research, scientific investigation, and research operations, the manager provides strategic and operational leadership across multiple clinical studies, supervises clinical research staff, and collaborates with physicians, scientists, computational researchers, and institutional research teams to ensure rigorous and efficient study execution.

Requirements

Bachelor’s degree in a related field with at least 7 years of experience, or a master’s degree in public health, biology, or clinical research with at least 5 years of experience managing clinical or human subjects research in an academic setting.
At least 2 years of experience training and supervising a team of clinical research staff.
Excellent strategic planning and project/program management skills, with demonstrated ability to lead complex projects from initiation through execution.
Data management expertise, including configuration and management of complex clinical research databases.
Experience collating requested subsets of data for clinical researchers.
Demonstrated multi-study program leadership across clinical, scientific, computational, and administrative teams, including management of simultaneous project portfolios, proactive problem-solving, and adherence to timelines and budgets.
Excellent written and verbal communication skills.
Exceptional organizational skills and attention to detail.
Analytical and problem-solving skills, with ability to make independent, effective decisions and exercise sound judgment.
Excellent interpersonal skills and ability to build productive working relationships with investigators, clinicians, research staff, institutional offices, and scientific collaborators.

Nice To Haves

Experience with investigator-initiated trials.
Experience with REDCap clinical research databases.
PMP training or certification.

Responsibilities

Manage day-to-day operations of multiple clinical research studies in inflammatory and immune-mediated conditions.
Work with principal investigators and multidisciplinary scientific teams to design, initiate, and implement human subjects research protocols and safety monitoring plans.
Supervise, train, and support Clinical Research Coordinators and other study staff, including oversight of recruitment, medical-record abstraction, biospecimen acquisition and processing, and data quality.
Coordinate study initiation and start-up activities and address regulatory, operational, and scientific requirements.
Prepare and submit human subjects research protocols, amendments, continuing reviews, and related materials to the Institutional Review Board.
Liaise among investigators, study staff, the Institutional Review Board, sponsors and funding organizations, core laboratories, and collaborating research teams.
Develop study operations manuals, standard operating procedures, Case Report Forms, and other study documentation.
Establish project plans, forecast milestones, track progress, identify risks and dependencies, and align projects with scientific and leadership goals.
Report study progress at investigator and project meetings and prepare study-related reports for research teams, funding organizations, and regulatory agencies.
Oversee clinical research databases and workflows to ensure data quality, integrity, and appropriate handling.
Coordinate collection, processing, tracking, and transfer of biospecimens for molecular analyses.
Facilitate approved sharing of data and biospecimens with collaborators in accordance with study protocols, Data Use Agreements, and institutional requirements.
Connect clinical cohorts and biospecimens with experimental and computational research across the program.
Participate in developing and implementing recruitment strategies for clinical studies.
Oversee study budgets and research expenditures and coordinate subcontracts or other agreements with participating institutes.