Clinical Research Project Manager
About The Position
The Clinical Research Project Manager works in the Office of Clinical Research (OCR) Center for Clinical Investigation (CCI) at Brigham and Women's Hospital. The role supports the design, planning, and management of research studies and clinical trials, developing and maintaining the infrastructure needed to support them. The Project Manager works with the Research Operations Director, department managers, and principal investigators, and supervises the Research Coordinator Network team. The position provides leadership and coordination among investigators, research sites, and sponsors; manages study start-up and operational activities; and oversees regulatory submissions, study documentation, training, and program operations. The role also leads departmental therapeutic program management from an administrative and regulatory perspective and collaborates with CCI staff on regulatory and study-related training and implementation.
Requirements
- Bachelor's degree in a related field required; experience in lieu of a degree is not accepted.
- 5–7 years of research-related experience required.
- Extensive knowledge of federal and state regulations governing clinical research, good clinical practice guidelines, regulatory guidance, and local policies.
- 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.
Nice To Haves
- Master's degree in a related field preferred.
- 1–2 years of supervisory experience preferred.
Responsibilities
- Serve as a liaison among investigators, research 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, assign, and coordinate regulatory, compliance, and sponsor study start-up activities with the project management team.
- Foster a team environment and lead special project oversight as requested.
- Submit IRB applications and required reports, including commercial IRB submissions and cede review applications.
- Manage site regulatory documents and binders.
- Manage ClinicalTrials.gov postings.
- Assist with preparation of 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 departmental therapeutic program management pipelines from an administrative and regulatory perspective.
- Maintain program tracking, utilization, operational documentation, and procedures.
- Oversee clinical research coordinators 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 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
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
