The role of Program Manager (PM) was created to lead and direct the Clinical Trials Office Disease Specific Portfolio Teams. PMs are responsible for the coordination of CTO study staff, investigators, sponsors, and oversight entities throughout the lifecycle of all clinical trials within their disease portfolio which includes 1st in human, high risk, phase I-III research. The PM is integral in ensuring optimal resourcing and utilization of CTO, MCC, University of Minnesota, Fairview, and M Health resources. CTO Program Managers have extensive knowledge of the intricacies involved with clinical trial initiation, ongoing trial management, significant milestones, and required team deliverables (e.g., concept development, resource review and allocation, budgeting and contracting, regulatory reviews, data management.) The PM position is a key element of the MCC prioritization process mandated by the National Cancer Institute (NCI) as part of the Cancer Center Support Grant (CCSG).
1. MCC Clinical Trial Portfolio Management and Oversight 60%
a. Leads and directs the day to day workload activities of regulatory specialists, research nurses, and clinical research associates in their designated disease specific portfolio, including prioritization of efforts related to assigned pending and active clinical research trials through the closing and termination. b. Performs planning and implementation for investigators on resourcing needs required to advance clinical research and assist investigators in gaining access to respective resources. This includes identification and coordination of internal and external stakeholders (e.g., biostatistics, recruitment, informatics consulting, regulatory, finance, data management, study coordination, outside industry sponsors, cooperative groups, University consortiums, etc.). c. 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 CTO portfolio activities. Applies them to the design, conduct, performance, monitoring, recording, analysis and reporting of clinical trials to the protecting the safety and health of human subjects and meeting regulatory compliance requirements. d. Strategize, develop and implement individual clinical research project plans including trial timelines, regulatory pathways, budgeting and contracting plans for the life cycle of the clinical trial. e. Leads weekly meetings with regulatory specialists, research nurses, clinical research associates, Principal Investigators and Faculty Clinical Research Officers (FCRO). f. Increases designated CTO Pod and department efficiency through monitoring staff workload and collaborate with hiring manager on both current and pipeline staffing requirements to project future resourcing needs.
2. MCC CTO Operational Management 25%
a. Works with the hiring manager to collaborate on interviewing, hiring of new employees, orientation and onboarding of new employees in the designated CTO Pod. This includes providing insight and decision-making related to employee orientation and onboarding plan, employee annual performance reviews, employee improvement plans and termination of employees. b. Ensures the designated CTO Pod team training development and mentoring plan is followed for each Pod team member. c. Serves as a key member of the CTO Management Team. Works to modify practices and procedures to improve efficiencies across the department and pod. d. As part of the CTO Management Team, works with Masonic Cancer Center leadership to continue to enhance the development and growth of the CTO Pod programs and strategic goals. This includes the Masonic Cancer Center, Academic Health Center and University of Minnesota wide research programs.
3. Research Conduct Review and Compliance (Independent of Pod) 15%
a. Oversee multiple process improvement projects within Clinical Trials Office (CTO) utilizing knowledge of clinical trial workflow, federal and state regulations to develop new processes and procedures to aid in the advancement of Cancer Center research. Demonstrate an extensive knowledge of NCI designations, the FDA Code of Federal Regulations (CFR) and Good Clinical Practices, which set the standards for the conduct, performance, monitoring, recording, analysis and reporting b. Reviews monitoring reports, data quality responsiveness, identifies and resolves problems with determined action plans with CTO processes and resourcing. c. Leads audit teams, Corrective and Preventative Action (CAPA) plans and is the liaison between the sponsor, investigator and governing body. i. Creates and maintains detailed clinical trial budgets/contracts and resolves budget deficits or financial queries. ii. Oversees completeness of Clinical Trials Management System-OnCore, CT.gov, SIP Flowchart and Disease specific algorithms. iii. Actively participates in University of Minnesota research committees, such as Fairview Community site team, OnCore Service Group, CTO Operations group and MCC Faculty Clinical Research Officers (FCRO) group.
BA/BS degree and at least six years of relevant experience or advanced degree with at least four years relevant experience.
Experience with clinical and/or translational research
Certified Clinical Research Coordinator (CCRC) or Certified Clinical Research Professional (CCRP) certification, or equivalent (e.g., RAC)
Experience with regulatory aspects (e.g. IRB and FDA) of conducting clinical research.
Experience in the management of resources and research projects.
Experience leading teams and delegating or assigning work tasks.
Ability to work with investigators of all experience levels, senior level administrators as well as technical staff.
Strong organizational skills, including evidence of ability to multi-task.
Excellent verbal and written communication skills.
Experience working with diverse populations.
BA/BS degree in health, public health or biomedical disciplines.
Advanced degree in health or biomedical discipline or public health.
Advanced level skills in Microsoft Word and Microsoft Excel.
Familiarity with academic medical centers, particularly the University of Minnesota system and processes strongly preferred.
The University of Minnesota, founded in the belief that all people are enriched by understanding, is dedicated to the advancement of learning and the search for truth; to the sharing of this knowledge through education for a diverse community; and to the application of this knowledge to benefit the people of the state, the nation, and the world.