If interested in this opportunity, please visit www.mghcareers.org and apply for JOB ID# 3146103
The Clinical Research Project Manager works independently to coordinate and oversee a portfolio of MGH-led, Investigator-initiated, multi-center clinical research trials. The Project Manager will provide direct trial management in addition to supervising and instructing a team in the coordination and monitoring of a larger portfolio of studies. The Project Manager is responsible for timeline management, clinical quality assessment of trial operations and ensuring compliance with the regulatory responsibilities of the Sponsor Investigator.
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
Acting as central communications liaison for all clinical trial collaborators
Working 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
Identifying variance across participating sites’ Standard Operating Procedures and developing processes to ensure compliance
Routine and expedited reporting to all funding sponsors, monitoring boards, regulatory boards or other governing agencies (e.g. FDA, IRB, DSMB, etc)
Hiring and training of new staff and assessment of ongoing continuing education and development needs of supervisees
First-line supervision and direction of junior program staff, especially on coordination of their own research portfolio and assistance with prioritization of project assignments
Executing performance evaluation, staff development and corrective action and processes for direct report research staff, as needed
Assisting and consulting with Senior Program Management on global program initiatives, including networking, program expansion and process improvement
Staying current with federal and local regulations, guidance and quality assurance trends as they pertain to the conduct of clinical research.
Domestic travel required (<25%)
Minimum 5 years related experience required
Exceptional project management, time management and organization skills
Excellent written and verbal communication skills
Strong leadership skills and the ability to effectively train and supervise others
Ability to work independently and demonstrate initiative and accountability
Ability to identify problems and develop creative and effective solutions
Demonstrated ability to successfully manage multiple projects and tasks
Ability to establish rapport with myriad associates and work collaboratively to resolve issues
Familiarity with the Code of Federal Regulation (CFR) and Good Clinical Practice (ICH GCP)
Knowledge of current and developing clinical research trends
Duties will primarily be performed in a remote work setting with occasional in-office presence.
Up to 25% domestic travel required
Position focuses on central trial coordination and does not include patient contact
Internal Number: 3146103
About Mass General Hospital
Massachusetts General Hospital is an Equal Opportunity Employer. By embracing diverse skills, perspectives and ideas, we choose to lead. Applications from protected veterans and individuals with disabilities are strongly encouraged.