Clinical Research Manager

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Mass General Brigham Incorporated

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.

The Program for the Coordination and Oversight of Research Protocols (PCORP) within the MGH Cancer Center Protocol Office specializes in the central coordination, monitoring and regulatory oversight of Investigator-initiated, multi-center clinical trials. PCORP is seeking candidates experienced in clinical trial coordination and implementation to provide managerial, operational and supervisory oversight for a team of research coordinators/monitors and their respective research trials.

The Clinical Research Project Manager will independently direct a team of research staff to coordinate, monitor and advance a portfolio of therapeutic oncology trials from concept through completion. Project Manager responsibilities include direct management of individual trials in addition to the hiring, training, and first-line supervision a team of research staff and the day-to-day operations of their research portfolios. The Project Manager has oversight responsibility of the team’s timeline management, clinical quality assessment and trial operations integrity and for ensuring Sponsor-Investigator and Site Investigator compliance with Federal and local regulatory requirements.

The Clinical Research Manager provides input into the assessment of program procedures and staff management, while maintaining a working knowledge of all aspects of clinical research management.

• Trial and portfolio coordination
• Coordination, regulatory maintenance, monitoring and timeline management of several multi-center clinical trials within the Cancer Center
• Ongoing evaluation and verification of protocol procedures, regulatory and data compliance and alignment with federal and local regulations across all participating sites
• Act as central communications liaison for all clinical trial collaborators
• Work directly with entities within and outside the organization, including Investigators, funding sponsors, collaborators and vendors to establish workflow, monitor process and identify and resolve issues
• Identify variance across participating sites’ Standard Operating Procedures and develop processes to ensure compliance
• Fulfill routine and expedited reporting requirements to all funding sponsors, monitoring boards, regulatory boards or other governing agencies (e.g. FDA, IRB, DSMB, etc)
• Occasional domestic travel as required

• Provide first-line supervision to a minimum of 2-4 FTEs and/or assist with specialized management projects of equivalent responsibility
• Hiring and training of new staff and assessment of ongoing continuing education and development needs of supervises
• Executing performance evaluation, staff development and corrective action processes for direct report research staff, as needed
• Manage staff productivity and quality of work produced by assessing work effort on individual studies

• Assist and consult with Senior PCORP Management on global program initiatives, including networking, program expansion and process improvement
• Stay current with federal and local regulations, guidance and quality assurance trends as they pertain to the conduct of clinical research. Assist in updates and development of program operations to align with guidance

• Exceptional time management skills with the capacity to prioritize among multiple tasks and change direction in response to fluctuating demands
• Excellent written and verbal communication skills
• Ability to clarify and distill complex issues to a variety of collaborators
• Able to work successfully and independently in a remote environment while demonstrating and fostering initiative and accountability
• Able to manage diverse teams with different skillsets, work styles, and professional roles
• Motivated to help team achieve results and meet deadlines
• Identifies key priorities and helps manage change and ambiguity
• Keen ability to anticipate and address potential issues proactively
• Problem-solving skills, including the ability to gather information, identify resources, and develop alternatives
• Familiarity with the Code of Federal Regulation (CFR) and Good Clinical Practice (ICH GCP)
• Knowledge of current and developing clinical research trends
• Sound interpersonal skills

The position reports directly to the Sr Project Manager and/or Project Director of a large global clinical study. This position has management responsibility for specific roles within a clinical study assigned to support the day-to-day operational…