University of Wisconsin - Madison

Position Vacancy Listing

PVL # 237829

Position Summary:
The Clinical Research Program Manager will function on the Management Team within the Clinical Research Disease Oriented Teams (DOT), serving at the direction of the Assistant Director of Clinical Research for the University of Wisconsin Carbone Cancer Center (UWCCC) and the Clinical Research Central Office Faculty Director. The incumbent will provide clinical support, leadership, and supervision to one or more Disease Oriented Teams as it pertains to Phase I, II and Phase III clinical research study activation, protocol compliance, study conduct, and completion. The incumbent must be able to handle multiple projects simultaneously and work independently using initiative and good judgment.

The School of Medicine and Public Health has a deep and profound commitment to diversity both as an end in itself but, also as a valuable means for eliminating health disparities. As such, we strongly encourage applications from candidates who foster and promote the values of diversity and inclusion.

Principal duties:
Primary duties include:

1. Along with Clinical Research Investigators initiate the development of new protocols and coordinate efforts to implement UWCCC investigator-initiated trials, industry sponsored trials, and federally sponsored trials, including complex multi-disciplinary protocols that involve multifaceted collaborations with numerous entities. Assist Clinical Research Investigators with clinical protocol development, preparation and submission of research grants, study proposals, progress reports, posters, manuscripts, and abstracts. Foster development of and advancement towards DOT program goals, together with the DOT Faculty Leaders.

2. Communicate and coordinate with the leadership team of the Clinical Research Central Office (CRCO), including the Faculty Director, the Assistant Director of Clinical Research, and members of the Financial, HR, Informatics, Compliance/Quality Assurance, Operations, and Education teams updating them both verbally and in written form of DOT activities, priorities, needs, strategies, and accomplishments. Administer DOT budgets to ensure staffing expenses are appropriate relative to the demands of the work and that DOTs are operating near fiscal solvency.

3. Communicate and coordinate with the Central Regulatory Team to oversee the preparation and collection of regulatory documents and submission to regulatory authorities. Ensure appropriate filing systems are established, all study documentation is accessible to auditors and maintained in good order, and facilitate good communication between the DOT, DOT Investigators, and the Regulatory Team. This includes applying for and management of applications for Investigational New Drug (INDs) with the FDA when required.

4. Directly supervise the DOT Clinical Team Managers and Activation Coordinators. The management of this staff includes: direct day-to-day supervision, training, mentorship and evaluation of the staff, and providing coverage when needed.

5. Work with fiscal, payroll and grants management staff to ensure program activities and expenditures are in compliance with the terms of grants and/or granting agencies.

6 Act as liaison between Sponsor Agencies (e.g. National Cancer Institute, Pharmaceutical Companies, and Partnering Universities) and internal study team communicating study timelines, while proposing and implementing solutions to problems that jeopardize the schedule or quality of studies. Assistance with education of and document creation for DOT Standard Operating Procedures, Tutorials, Guidance and supplementation forms which support clinical data collection, subject recruitment, organizational management of University's requirements and overall efficient study conduct.

7. This Program Manager is expected to follow the policies, procedures, guidelines, and standards for excellence and professionalism established by the UWCCC and the University of Wisconsin. Additionally, this position will assure that all research activity adheres to Federal, State and University policies, procedures and requirements.

8. Participate in UWCCC committees in order to further the mission of the Cancer Center. Disseminate information to DOT from UW and UWCCC meetings and committees. Provide back-up for the Cancer Center with coordination and coverage of other key management positions as needed to maintain consistency in the program. Interface with other departments to provide education and facilitation for understanding of oncology clinical trials within the research community.

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