Site: The Brigham and Women's Hospital, Inc.
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.
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
• 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 Experience Research Related Experience 5-7 years required and Supervisory Experience 1-2 years preferred Knowledge, Skills and Abilities - 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. - Must possess strong budget management skills.
Additional Job Details (if applicable)
Remote Type
Hybrid
Work Location
221 Longwood Avenue
Scheduled Weekly Hours
40
Employee Type
Regular
Work Shift
Day (United States of America)
Pay Range
$63,252.80 - $102,596.00/Annual
Grade
7
At Mass General Brigham, we believe in recognizing and rewarding the unique value each team member brings to our organization. Our approach to determining base pay is comprehensive, and any offer extended will take into account your skills, relevant experience if applicable, education, certifications and other essential factors. The base pay information provided offers an estimate based on the minimum job qualifications; however, it does not encompass all elements contributing to your total compensation package. In addition to competitive base pay, we offer comprehensive benefits, career advancement opportunities, differentials, premiums and bonuses as applicable and recognition programs designed to celebrate your contributions and support your professional growth. We invite you to apply, and our Talent Acquisition team will provide an overview of your potential compensation and benefits package.
