Clinical Research Project Manager

Mass General Brigham • Boston, MA

14h • Hybrid

About The Position

The Brigham and Women’s Hospital, Inc. is seeking an intellectually curious and highly organized Clinical Research Project Manager with an interest in or experience with clinical trials. The position is based in the Office of Clinical Research (OCR) Center for Clinical Investigation (CCI) and works with the Research Operations Director, department managers, and principal investigators. The Project Manager supervises the Research Coordinator Network (RCNet) team and supports the OCR/CCI mission of strengthening clinical research by providing services to investigators and facilitating their success.

The role develops and maintains the infrastructure for research studies and clinical trials, supporting their design, planning, and management. It provides leadership and operational oversight across regulatory activities, study documentation, research teams, and therapeutic program management. The position also collaborates with CCI staff on regulatory and study-based training and presents regulatory status for a disease-group portfolio at applicable research meetings.

This is a regular, full-time position with a hybrid work arrangement, a day shift, and 40 scheduled weekly hours. The listed annual pay range is $63,252.80 to $102,596.00. The role requires a bachelor's degree in a related field; a master's degree in a related field is preferred. Five to seven years of research-related experience is required, and one to two years of supervisory experience is preferred.

Requirements

• Bachelor's degree in a related field required; experience in lieu of a degree is not accepted.
• Five to seven years of research-related experience 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 and problem-solving skills.
• Strong budget management skills.
• Extensive knowledge of federal and state regulations governing clinical research, good clinical practice guidelines, regulatory guidance, and local policies.

Nice To Haves

• Master's degree in a related field.
• One to two years of supervisory experience.

Responsibilities

• Provide leadership as a liaison among investigators, sites, and sponsors.
• Develop plans for projects, follow up on discussions, and request project updates.
• Meet regularly with research teams to review trial projects, timelines, and action items.
• Manage and assign regulatory, compliance, and sponsor study start-up activities with the project management team.
• Foster a team environment and lead additional special project oversight as requested.
• Develop and maintain study and clinical-trial infrastructure by supporting design, planning, and management.
• Submit IRB applications and required reporting, including commercial IRB submissions and cede review applications.
• Manage site regulatory documents and binders, and manage ClinicalTrials.gov postings.
• Assist with preparing protocols, informed consent forms, and recruitment materials.
• Oversee preparation and maintenance of Manuals of Procedures and site and staff training materials.
• Manage the study portal and access to study documents and trial materials.
• Lead the departmental therapeutic program management pipeline from an administrative and regulatory perspective.
• Maintain tracking, utilization, and operational documentation and procedures for the program.
• Oversee the clinical research coordinator assigned to the studies and cross-functional teams implementing the program area.
• Lead and collaborate with CCI staff to implement regulatory and study-based training and the implementation of new or revised regulations, guidance, and local policies.
• Present regulatory status for the disease-group portfolio at applicable research meetings.

Benefits

• Comprehensive benefits.
• Career advancement opportunities.
• Differentials, premiums, and bonuses as applicable.
• Recognition programs designed to celebrate contributions and support professional growth.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager