Senior Clinical Research Programs Lead

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

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