Fred Hutchinson Cancer Research Center (“Fred Hutch”, “the center”) is one of the premier cancer research centers in the world and home to three Nobel laureates. Fred Hutch is an independent, nonprofit research institution, located on a magnificent campus in the South Lake Union area of Seattle. With the mission of eliminating cancer and related diseases as causes of human suffering and death, the center conducts research of the highest standards to improve prevention and treatment of cancer and related diseases. Recognized internationally for its pioneering work in bone marrow transplantation, the Fred Hutch’s five scientific divisions collaborate to form a unique environment for conducting basic and applied science.
In order to fulfill its mission, Fred Hutch is dedicated to:
The scientific palette of Fred Hutch is extensive; it has over 270 research scientists and 2,800 employees. Areas of research focus include hematologic malignancies, solid tumor biology, immunotherapy, early detection, tumor research, international research, fundamental science, cancer and prevention research as well as substantial programs in global oncology and HIV/AIDS. Additionally, given that the eradication of cancer and other life-threatening diseases is an ambitious goal that demands tenacity, scientific excellence, collaboration and breakthrough creativity, Fred Hutch has five scientific divisions working toward this end: Basic Sciences, Clinical Research, Human Biology, Public Health Sciences, and Vaccine and Infectious Disease. The center has recently established crosscutting integrated research centers organized to promote team science involving members from two or more of the scientific divisions.
The Clinical Trials Management System (CTMS) Program Director drives the implementation and the transition to ongoing operations of the CTMS Program across the Fred Hutchinson Cancer Research Center (FHCRC), the Seattle Cancer Care Alliance (SCCA), and UW Medicine. This position will work collaboratively with leadership at Fred Hutch, 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. As leader of the CTMS Program and its implementation across the tri-institutional partnership, this individual promotes strong CTMS Program governance standards, leads the achievement of program goals, ensures effective CTMS Program communications to stakeholders, provides fiscal oversight to the CTMS Program and manages resources according to approved budget, and successfully manages change initiatives associated with the implementation 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 at Fred Hutch. At a functional level, the CTMS Program Director is the primary representative of the CTMS Program for this tri-institutional partnership, and is ultimately accountable to the CTMS Executive Sponsor Committee.
The CTMS Program supports clinical trials across three institutions with tri-institutional governance. The CTMS Program is a collective initiative of the Hutch, SCCA, and UW Medicine to implement and manage an enterprise-level software resource to support clinical trials conducted across and within this tri-institutional partnership. Through its support of oncology and non-oncology clinical trials, 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 Fred Hutch, SCCA, and UW Medicine to achieve the guiding principles of the CTMS Program through cooperative efforts of their respective staff. The position will be responsible for the CTMS Program budget planning, management, and reporting to the CTMS Executive Sponsor Committee, ensuring that the resources are aligned with and able to support the CTMS goals across the partner institutions.
The CTMS supports multiple aspects of the clinical trial lifecycle: initial protocol and scientific reviews, the translation of protocol events to procedure and visit calendars, pre-budget procedure coding and coverage analyses, budget development, sponsor negotiation, subject visit tracking and documentation, and sponsor invoicing. Although the CTMS Program will not directly manage the operations of all functions supported by the CTMS, the CTMS Program Director should have working knowledge and understanding of these aspects of the clinical trial lifecycle to ensure that the CTMS Program is providing the necessary and appropriate services in support of the tri-institutional partnership’s research missions.
The CTMS Program Director is responsible for implementation and operationalization of the CTMS Program. This role has a key responsibility to maintain continuity of the CTMS Program during its implementation phases and throughout its multi-year transition to ongoing operation and service delivery. This position directs the activities of the project managers and teams who are tasked with implementing the CTMS and of managing the associated changes resulting from the implementation. This position is also responsible for bringing online the operations of the CTMS Program Office, directing its staff, and for the service delivery to the tri-institutional partners. The distribution of implementation and operation responsibilities for this position will transition from implementation-focused to operations-focused as the CTMS Program progresses through the multi-year implementation plan.
The CTMS Program Director is accountable to a three-party governance structure. The governance of the CTMS Program reflects the collaboration of leadership from the partner 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. 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.
POSITION DIMENSIONS AND IMPACT
The CTMS Program Director will be responsible for ensuring that the CTMS Program realizes its goals of supporting efficient clinical research study implementation, processes, finances, and reporting, all which further improve the experiences of patients on clinical trials. This role will continuously work with peers in the tri-institutional partnership to develop and manage CTMS-relevant processes and data governance to accomplish these goals. This role will provide leadership to the CTMS Program and both strategic and tactical support to the CTMS Executive Sponsor Committee to achieve the objectives of the CTMS Program.
The leadership of the CTMS Program Director will drive the successful implementation of the CTMS Program over its multi-year implementation phases. During implementation, this role must also gradually bring online various CTMS Program functions as they transition from implementation to full operation. To successfully direct the CTMS Program, this role must efficiently lead implementation while also maintaining a clear vision of transitioning to and directing the CTMS Program’s ongoing operations in future years.
Institutional partners will rely upon information managed within the CTMS to support reporting requirements to regulatory, funding, and clinic billing agencies. The CTMS Program Director is responsible for ensuring the quality of the data within the CTMS by directing quality control and assurance functions. This role will work with technical partners within the institutions to establish controls and policies that govern technical transactions and interfaces with the CTMS, and that maintain valid report development and generation.
DUTIES AND RESPONSIBILITIES
The CTMS Program Director is a full-time role consisting of the following duties and responsibilities.
CTMS Program Leadership and Strategy – <Anticipated 40% FTE throughout Implementation to Operations>
CTMS Program Implementation and Operational Transition – <More % FTE initially, decreasing to 0% at full operations>
CTMS Program Office Management – <Less % FTE initially, increasing to 60% at full operations>
PEER AND PARTNER RELATIONSHIPS