Sr. Project Manager: Minnesota Cancer Clinical Trials Network

The Minnesota Cancer Clinical Trials Network (MNCCTN) is a multi-site cancer clinical trials network. The network, led by the Masonic Cancer Center at the University of Minnesota, brings cancer clinical trials from the Masonic Cancer Center, Hormel Institute, and the Mayo Clinic Cancer Center to community sites across the state. As a growing program, MNCCTN offers qualified candidates the opportunity to shape the direction and implementation of cancer clinical research across the state.

The Sr. Project Manager reports to MNCCTN’s Senior Manager and works closely with MNCCTN Partners and sites, investigators and study teams from the UMN and Mayo Clinic Cancer Center, UMN Masonic Cancer Center’s CTO, CTSI, and other research groups or organizations.

As a key member of the MNCCTN HUB team, the Sr. Project Manager’s primary responsibility is for the oversight and management of the network’s portfolio of multi-site cancer clinical trials. Using their knowledge of clinical trial lifecycles, the Sr. Project Manager’s role is to plan and implement successful multi-site cancer clinical trials across the state at over twenty clinical sites. The Sr. Project Manager is expected to understand clinical trial development, start-up, implementation, milestones, and deliverables to provide expert guidance to study teams working with the network. The Sr. Project Manager will also be expected to participate in the development of the network’s processes and policies with a focus towards sustainability and growth.

A successful applicant will be highly organized, able to oversee multiple projects in various stages of development, and work collaboratively with a wide variety of internal and external stakeholders.

MNCCTN Clinical Trial Portfolio Management and Oversight 75%

Clinical Trial Pipeline Development
•Assist in identifying appropriate UMN cancer trials for MNCCTN. Meet with departments, divisions, and individual investigators and study teams to discuss collaboration on studies. Provide overview of MNCCTN requirement, processes, workflows, and expectations.
•Guide investigators and study teams through assessing whether and how studies could be implemented through the MNCCTN.

Trial Review, Start-Up, and Execution
•Provide guidance and recommendations to investigators and study lead team on research plan to ensure trial design is appropriate for and executable in a multi-site network.
•Manage trial review processes including HUB quality review, preparing protocols and documents for feasibility and scientific review, oversee requested revisions or updates, final approval by Steering committee, and final feasibility.
•Collaborate and provide guidance to investigators on study implementation for MNCCTN. This includes identification and coordination of internal and external stakeholders such as investigational and site clinic pharmacies and biospecimen collection laboratory and pathology partners.
•Develop study budgets for MNCCTN and work with investigators and MNCCTN Sr. Manager to complete necessary contracting.
•In partnership with the MNCCTN Regulatory Specialist and others as needed, prepare study documents for Partner study start-up dissemination. This includes Manual of Procedures and Pharmacy or Lab manuals as well as regulatory and study management logs and checklists.
•Develop study training materials in collaboration with the study lead team and execute SIVs with Partners.
•Serve as the lead point of contact for research nurses and research coordinators across MNCCTN sites in efforts related to upcoming and active clinical research trials. Serve as point of contact for MNCCTN Operation Subcommittee members on issues related to study workflows and operationalization.
•Utilizes extensive knowledge and comprehension of Code of Federal Regulations (CFR), Good Clinical Practice (GCP) guidelines, and National Institute of Health (NIH) research rules to oversee MNCCTN portfolio activities. Applies them to all aspects of clinical trial activity for the protection of the safety and health of human subjects and meeting regulatory compliance requirements.

MNCCTN Operational Management 25%

•Serves as a key member of the MNCCTN Management Team. Works to implement and modify practices and procedures to improve efficiencies across the network.
•Define, improve, and evaluate workflow processes for MNCCTN between Partners, sites, investigators and study teams, and UMN groups (CTO, CTSI, etc.).
•Reviews monitoring reports, data quality responsiveness, identifies and resolves problems with determined action plans.
•Leads professional development and training initiatives aimed at site research nurses and coordinators
•Work with MNCCTN leadership to continue to enhance the development and growth of MNCCTN and its strategic priorities.
•Develops, maintains, and disseminates study progress reports as appropriate for specific MNCCTN stakeholders.
•Develops and maintains internal study progress tracking reports.
•Leads regular meetings with study teams through the initial introductory phase, protocol review, startup, and during active enrollment.
•Leads regular meetings with affiliate site research nurses and research coordinators to discuss study implementation, screening and enrollment progress, and site-specific study needs.