Clinical Research Program Manager

Broad Institute of MIT and Harvard; Cambridge (MA); On-site; USD 104,000 - 145,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Life insurance

Disability insurance

401(k) retirement plan

Flexible spending accounts / Health-sá

Job summary

The Broad Institute of MIT and Harvard is seeking a senior clinical research operations leader to oversee day-to-day management of multiple studies in inflammatory and immune-mediated conditions. You will design, initiate, and implement human subjects research protocols with PIs and multidisciplinary teams, while supervising coordinators and ensuring data quality and regulatory compliance.

You will coordinate start-up activities, prepare IRB materials, and serve as a key liaison among

Qualifications

• Bachelor's degree in a related field with 7+ years of experience or Master's degree with 5+ years in public health, biology, or clinical research; managing clinical or human subjects research in academia.
• Minimum 2 years of experience training and supervising a team of clinical research staff.
• Excellent strategic planning and project/program management skills with ability to lead complex projects.
• Data management expertise including configuration and management of complex clinical research databases.
• Proven track record of multi-study program leadership across clinical, scientific, computational, and administrative teams.
• Excellent written and verbal communication skills.

Responsibilities

• Manage day-to-day operations of multiple clinical research studies in inflammatory and immune-mediated conditions.
• Work with PIs and scientific teams to design, initiate, and implement human subjects research protocols and safety monitoring plans.
• Supervise, train, and support Clinical Research Coordinators and study staff, including recruitment, data quality, and biospecimen handling.
• Coordinate study initiation/start-up activities and ensure regulatory and scientific requirements are addressed efficiently.
• Prepare and submit human subjects research protocols and related materials to the IRB.
• Serve as liaison among investigators, IRB, sponsors, and collaborating teams.
• Develop study operations manuals, SOPs, CRFs, and other documentation.
• Establish project plans, milestones, risks, and ensure alignment with goals.
• Report progress at meetings and prepare study-related reports for sponsors and regulatory agencies.
• Oversee databases and workflows to ensure data quality and integrity.
• Coordinate collection/processing/transfer of biospecimens for molecular analyses.
• Facilitate data and biospecimen sharing with collaborators per Data Use Agreements.
• Connect clinical cohorts with experimental and computational research across the program.
• Participate in recruitment strategy development for clinical studies.
• Oversee study budgets and coordinate subcontracts.

Skills

Organizational skills

Analytical skills

Cross-functional collaboration

Project management

Education

Bachelor's degree in related field with 7+ years

Master's degree in public health/biology/clinical research with 5+ years

Job description

What You Will Do

• Manage the day-to-day operations of multiple clinical research studies in inflammatory and immune-mediated conditions.
• Work closely with principal investigators and multidisciplinary scientific teams to design, initiate, and implement human subjects research protocols and safety monitoring plans.
• Directly supervise, train, and support Clinical Research Coordinators and other study staff, including oversight of patient recruitment, medical-record abstraction, biospecimen acquisition and processing, and data quality.
• Coordinate study initiation and start-up activities and help ensure that regulatory, operational, and scientific requirements are addressed efficiently.
• Prepare and submit human subjects research protocols, amendments, continuing reviews, and related materials to the Institutional Review Board.
• Serve as a key liaison 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 ensure that projects remain aligned 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 the quality, integrity, and appropriate handling of clinical and research data.
• Coordinate the collection, processing, tracking, and transfer of biospecimens used for genomic, transcriptomic, immunologic, microbiome, metabolomic, single-cell, spatial, and other 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 conducted across the collaborative program.
• Participate in the development and implementation of recruitment strategies for clinical studies.
• Oversee study budgets and associated research expenditures and coordinate subcontracts or other agreements with participating institutes

How you work

• You bring exceptional organizational skills and attention to detail.
• Demonstrate analytical and problem-solving skills, makes independent, effective decisions and exercises sound judgment.
• Cross-functional collaborator with excellent interpersonal skills who builds productive working relationships with investigators, clinicians, research staff, institutional offices, and scientific collaborators.

Qualifications

• Bachelor’s degree in a related field with 7+ years of experience or Master’s degree in public health, biology, clinical research with 5+ years of experience managing clinical or human subjects research in an academic setting.
• Minimum 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.
• Proven track record of multi-study program leadership across clinical, scientific, computational, and administrative teams, orchestrating simultaneous project portfolios with proactive problem-solving, strict adherence to timelines and budget.
• Excellent written and verbal skills.

Preferred Experience

• Investigator initiated trials
• REDcap clinical research database
• PMP training or certification

Pay Range: $104,000.00/yr - $145,333.00/yr

The expected base pay range for this position as listed above is based on a 40 hour per week schedule. Broad provides pay ranges representing its reasonable and good faith estimate of what the organization reasonably expects to pay for a position at the time of posting. Actual compensation will vary based on factors including but not limited to, relevant skills, experience, education, qualifications, and other factors permissible by law.

At Broad, your base pay is just one part of a comprehensive total rewards package. From day one, this role offers a competitive benefits package including medical, dental, vision, life, and disability insurance; a 401(k) retirement plan; flexible spending and health savings accounts; at least 13 paid holidays; winter closure; paid time off; parental and family care leave; and an employee assistance program, among other Broad benefits.

The Broad Institute is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, national origin, religion, age, color, sex, disability, protected veteran status, or any other characteristic protected by local, state, or federal laws, rules, or regulations.

Should you need a reasonable accommodation to complete the application or interview process, please contact [e-mail] for assistance.