Clinical Research Project Manager
- Compensation
- Not disclosed
- Location
- Boston-MA
- Work setup
- Not specified
- Seniority
- Not specified
- Employment
- Not specified
- Experience
- Not specified
- Category
- Project management
- Posted
Skills
Must have
- The Project Manager will be responsible for developing and maintaining the infrastructure of research studies and clinical trials by supporting the design, planning, and management of the projects.
- Principal Duties and Responsibilities:
- Provides strong leadership as a liaison between the investigators, sites, and sponsors. This includes:
- · 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, including the following:
- 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
- · Manage study portal and access to study documents and trial materials
- • 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 meetingTs
- Education Bachelor's Degree Related Field of Study required or Master's Degree Related Field of Study preferred Can this role accept experience in lieu of a degree? No Licenses and Credentials Experie
Full description
Site: The Brigham and Women's Hospital, Inc.
Mass General Brigham relies on a wide range of professionals, including doctors, nurses, business people, tech experts, researchers, and systems analysts to advance our mission. As a not-for-profit, we support patient care, research, teaching, and community service, striving to provide exceptional care. We believe that high-performing teams drive groundbreaking medical discoveries and invite all applicants to join us and experience what it means to be part of Mass General Brigham.
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.
The mission of the OCR/CCI is to strengthen the culture for clinical research at the Brigham and Women’s Hospital by building services helpful to clinical investigators and facilitating the success of individual investigators.
Qualifications
The Project Manager will be responsible for developing and maintaining the infrastructure of research studies and clinical trials by supporting the design, planning, and management of the projects.
Principal Duties and Responsibilities:
Provides strong leadership as a liaison between the investigators, sites, and sponsors. This includes:
· 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, including the following:
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