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The Clinical Trials Management System (CTMS) Program Director coordinates the strategy and operations of the CTMS Program to support clinical research operations across the Fred Hutchinson Cancer Research Center (FHCRC), the Seattle Cancer Care Alliance (SCCA), and UW Medicine. These three institutions have joined in an effort to establish a uniform CTMS that will support all clinical trials at the three institutions. This position will work collaboratively with leadership at FHCRC, SCCA, and UW Medicine to establish and lead a CTMS Program Office that serves the full spectrum of oncology and non-oncology trials at FHCRC, SCCA, and UW Medicine, utilizing the OnCore® clinical trial management system. The system supports over 500 end users with over 3,000 clinical research studies (50% FH/UW oncology and 50% UW non-oncology). As leader of the CTMS Program across the tri-institutional partnership, this individual develops and promotes strong CTMS Program standards, leads the achievement of program goals, ensures effective CTMS Program communications to stakeholders, provides fiscal oversight to the CTMS Program, and successfully manages operations and adoption of the CTMS Program. As Director of the CTMS Program, this position is responsible for achieving the operational standards and service agreements established by the tri-institutional partnership to govern the CTMS Program. This position has a direct supervisory report to the VP of Research Administration at FHCRC, a member of the CTMS Executive Sponsor Committee. The director is responsible to the CTMS Executive Sponsor Committee, which consists of equal numbers of Executive Sponsors from each of the three institutions, for overall operations of the CTMS in a manner that serves the needs of clinical trialists at each of the three institutions. This position will oversee a team of 8-15 staff (increasing as system functionality is implemented), with HR supervisory accountabilities and vendor/contract management accountabilities. Through the completion of system implementation, the CTMS Executive Sponsor Committee and the CTMS Program Office Director will be jointly accountable for the Implementation.
The CTMS Program is a collective initiative of the FHCRC, SCCA, and UW Medicine to facilitate clinical trial management workflows and provide operational support for clinical research conducted within the tri-institutional partnership. Through its support of clinical trials in all disease states, the CTMS Program provides core functions within the research missions of the partner institutions. Therefore, the individual in this position must effectively navigate, operate, and lead the CTMS Program within a varied, multi-institutional environment and matrixed reporting structure. The CTMS Program Director will have direct oversight of managers and staff within the CTMS Program Office; and will work in partnership with collaborators at FHCRC, SCCA, and UW Medicine to achieve the guiding principles of the CTMS Program through cooperative efforts of their respective staff.
The CTMS Program Director is accountable to a three-party equally balanced governance structure. The governance of the CTMS Program is a result of the shared interest and commitment of the collaborating institutions. The CTMS Executive Sponsors hold the ultimate responsibility for the success of the CTMS Program and Office, and the performance of the CTMS Program Director. Success is defined, in part, by meeting the needs of clinical trials across disease states and institutions. This position will have performance accountability, including CTMS Program budget and fiscal management as well as achievement of the Program Office performance goals, to the institutional partners, through the CTMS Executive Sponsors and Committee.