Clinical Research Project Manager
Mass General Brigham
Summary
We are seeking an intellectually curious and highly organized individual with clinical trial interest/experience to serve as a Project Manager in the Office of Clinical Research (OCR) Center for Clinical Investigation (CCI). The candidate will work with the Research Operations Director, Department Managers, and Principal Investigators. The Project Manager will supervise the Research Coordinator Network (RCNet) team.
Job description
Job Summary
We are seeking an intellectually curious and highly organized individual with clinical trial interest/experience to serve as a Project Manager in the Office of Clinical Research (OCR) Center for Clinical Investigation (CCI). The candidate will work with the Research Operations Director, Department Managers, and Principal Investigators. The Project Manager will supervise the Research Coordinator Network (RCNet) team.
Principal Duties and Responsibilities
Provides strong leadership as a liaison between the investigators, sites, and sponsors.
- Developing a plan for all projects and ensuring follow-up on all discussions, and requesting an update on projects.
- Meeting with the research teams regularly to review trial projects, timelines and action items
- Manage, assign and regulatory, compliance and sponsor study start-up activities along with the project management team
- Foster a team environment
- Lead additional special project oversight as requested
Operational Management
Develop and maintain the infrastructure of studies and clinical trials by supporting the design, planning, and management activities.
Regulatory
- Submit IRB Applications and required reporting, including commercial IRB submissions and cede review applications
- Manage site regulatory documents and binders
- Manage ClinicalTrials.gov postings
Study documents
- Assist in preparation of protocol and informed consent forms
- Assist with recruitment materials
- Oversee preparation and maintenance of Manuals of Procedures
- Oversee site and staff training materials
- Manage study portal and access to study documents and trial materials
Leadership
- Lead 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 these studies
- Oversee cross functional teams that implement this program area
- Extensive knowledge of federal and state regulations governing clinical research, and good clinical practice guidelines, regulatory guidance and local policies
- Lead and collaborate with CCI staff to implement regulatory and study based training and implementation of new or revised regulation, guidance and or local policy
- Present regulatory status for disease group portfolio at applicable research meetings
Requirements
- Bachelor's Degree in a related field of study required
- Master's Degree in a related field of study preferred
- Experience cannot be accepted in lieu of a degree
- 5-7 years of research-related experience required
- 1-2 years of supervisory experience preferred
- Extensive knowledge of federal and state regulations governing clinical research
- Knowledge of 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 skills to problem solve effectively
- Strong budget management skills
Benefits
- Comprehensive Benefits
- Career Advancement Opportunities
- Differentials
- Premiums
- Bonuses
- Recognition Programs
Company overview
Mass General Brigham is one of the largest integrated healthcare delivery systems in the United States, formed through the merger of Massachusetts General Hospital and Brigham and Women's Hospital. Based in Boston, Massachusetts, this academic medical center system operates multiple hospitals, specialty facilities, and community health centers throughout New England. The organization is renowned for its world-class patient care, cutting-edge medical research, and comprehensive medical education programs. As a teaching affiliate of Harvard Medical School, Mass General Brigham trains the next generation of healthcare professionals while advancing medical science through groundbreaking research initiatives. The system provides a full continuum of healthcare services, from primary care and preventive medicine to complex specialty treatments and emergency services. With a focus on innovation and patient-centered care, Mass General Brigham consistently ranks among the top hospital systems in the nation for clinical excellence and research output.