All required qualifications must be documented on application materials.
- BA/BS degree and at least six years of relevant experience or advanced degree with four years of experience.
- Experience with clinical and/or translational research
- Certified Clinical Research Coordinator (CCRC) or Certified Clinical Research Associate (CCRA) certification, or equivalent (i.e., RAC)
- Experience with regulatory aspects (institutional and FDA) of conducting clinical research.
- Ability to work with investigators of all experience levels.
- Ability to work with senior level administrators as well as technical staff.
- Experience in the management of resources and research projects.
- Experience leading teams and delegating or assigning work tasks.
- Experience working with diverse populations.
- Demonstrated experience with public speaking.
- Strong organizational skills, including evidence of ability to multi-task.
- Advanced level skills in Microsoft Word and Microsoft Excel are essential.
- Excellent verbal and written communication skills.
- BA/BS degree in in health, public health or biomedical disciplines.
- Advanced degree in health or biomedical discipline or public health.
- Project Management Certification.
- Grant writing experience.
- Familiarity with academic medical centers, particularly the University of Minnesota system and processes strongly preferred.
About the Job
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.
About the Department
The Masonic Cancer Center creates a collaborative research environment focused on the causes, prevention, detection, and treatment of cancer; applying that knowledge to improve quality of life for patients and survivors; and sharing its discoveries with other scientists, students, professionals, and the community. Founded in 1991, the cancer center became a National Cancer Institute designated comprehensive cancer center in 1998, one of only 45 institutions in the United States to hold this designation, which is awarded only to institutions that make ongoing, significant advances in cancer research, treatment, and education.
Many choose to work at the Masonic Cancer Center, University of Minnesota because they believe in our mission and are excited by our vision for the future. We have a reputation as a great place to work, for our excellent leadership, and we are a strong community that values diversity. For more information about MCC, its programs, research, and faculty, please visit: cancer.umn.edu.
How To Apply
Applications must be submitted online. To be considered for this position, please click the Apply button and follow the instructions. You will be given the opportunity to complete an online application for the position and attach a cover letter and resume.
Additional documents may be attached after application by accessing your "My Activities" page and uploading documents there.
To request an accommodation during the application process, please e-mail email@example.com or call (612) 624-UOHR (8647).
The University recognizes and values the importance of diversity and inclusion in enriching the employment experience of its employees and in supporting the academic mission. The University is committed to attracting and retaining employees with varying identities and backgrounds.
The University of Minnesota provides equal access to and opportunity in its programs, facilities, and employment without regard to race, color, creed, religion, national origin, gender, age, marital status, disability, public assistance status, veteran status, sexual orientation, gender identity, or gender expression. To learn more about diversity at the U: http://diversity.umn.edu.
Background Check Information
Any offer of employment is contingent upon the successful completion of a background check. Our presumption is that prospective employees are eligible to work here. Criminal convictions do not automatically disqualify finalists from employment.
About the U of M
The University of Minnesota, Twin Cities (UMTC)
The University of Minnesota, Twin Cities (UMTC), is among the largest public research universities in the country, offering undergraduate, graduate, and professional students a multitude of opportunities for study and research. Located at the heart of one of the nation's most vibrant, diverse metropolitan communities, students on the campuses in Minneapolis and St. Paul benefit from extensive partnerships with world-renowned health centers, international corporations, government agencies, and arts, nonprofit, and public service organizations.
The University of Minnesota offers a comprehensive benefits package including:
Competitive wages, paid holidays, vacation and sick leave
Low cost medical, dental, and pharmacy plans
Health care and dependent daycare flexible spending accounts
Excellent retirement plans with employer match
Disability and employer paid life insurance
Wellbeing program with reduced insurance premiums
Tuition reimbursement opportunities covering 75%-100% of eligible tuition
Student loan forgiveness opportunity
Opportunities for growth and promotion
Employee Assistance Program
For more information regarding benefits: