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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.
Develop and maintain a 3-5-year CTMS Strategic Roadmap outlining the timing and sequencing for delivering key business capabilities and enhancements to the CTMS to support tri-institutional business needs over the long term. Partner with UW Director of Research IT to ensure integration of applicable system roll-outs.
Oversee Implementation and Business Operations team and ensure that: (a) implementation timeline of new functionality is in alignment with CTMS roadmap and operating model, and (b) there is optimal transition in each phase from implementation to operations.
In partnership with leadership of FH, SCCA and UW parallel offices, define and establish the Program Office business operational standards and service level agreements.
Work with stakeholders across the tri-institutional partnership to assure that the CTMS operations support the business requirements of all three organizations, including CTSA and NCI reporting requirements.
Lead Executive Sponsors Committee meetings reporting Program Office performance and volume metrics and escalating any existing or projected Program risks to meeting service level agreements.
Represent CTMS business operations in organizational process improvement efforts; identify new opportunities to leverage CTMS data across the institutions to improve transparency, efficiency, and compliance in clinical research-related operations.
Lead cross-institutional CTMS Data Standards Committee to ensure OnCore minimum data entry footprint and workflows support business requirements of tri-institutional stakeholders. Oversee quality control functions of data requirements and escalate ongoing compliance issues to Executive Sponsors as appropriate.
Manage end user system support functions according to service level agreements, including: facilitation of tri-institutional user access process, triaging end user workflow/data entry issues, maintaining user SOPs and training materials.
Establish and manage team(s) that perform high-volume operational tasks within OnCore including: oncology and non-oncology clinical trial calendar building, ensuring UW and SCCA chargemaster remains current within OnCore, and performing calendar-driven sponsor invoicing functions. Partner with parallel offices to ensure efficient integration with coverage analysis and budgeting functions performed outside of the Program Office.
Partner with the UW Director for Research IT for the technical management and support of the CTMS. Work in partnership to plan for technical maintenance and upgrades and assure business impacts are assessed and communicated to appropriate stakeholders.
Plan Program Office growth according to Implementation Plan and evolving business needs of tri-institutional partners. Utilize contract resources when appropriate and manage contracts and SOWs as needed.
Oversee and integrate the CTMS Implementation Plan into the operating model and budget, preparing for optimal operationalization of capabilities as it is delivered by the implementation team over a multi-year period.
Manage the overall CTMS Program Budget, seeking approvals, providing timely updates and variance metrics to the Executive Sponsors.
Recruit, train, motivate and manage CTMS Program Office staff. Develop and mentor staff based on goals, accountability, objectives, and priorities.
- Master's Degree in business administration, health administration, or related field or equivalent experience.
- Minimum five years of clinical research experience; includes relevant experience managing clinical research or enterprise system, transactional process operations, and service delivery.
- Minimum seven years of management-level experience; includes relevant experience managing the support functions of a research administration system in a business office of a university, hospital, or research institute.
- Familiarity with a comprehensive range of clinical research areas and disease groups; including experience in both oncology and non-oncology (e.g., cardiology, nephrology) clinical research areas.
- Demonstrated strong governance management in a matrixed setting, including the abilities to inform strategic decisions, to facilitate and negotiate through complex strategic decisions, to communicate with executive leadership, and to influence without authority when necessary.
- Solid foundation in data governance principles and experience managing large data sets.
Our Commitment to Diversity
- Understanding of research administration lifecycle processes, including but not limited to: study calendars, study and subject lifecycle management, budget development, research revenue cycle functionality, and general billing compliance.
- Knowledge of state and federal regulations governing clinical research; includes the application of the Medicare Clinical Trial Policy and other CMS rules and guidelines for NCI-Designated Comprehensive Cancer Centers.
- Proven ability to establish productive working relationships across large organizations, communicate well at all levels, and to work collaboratively in a highly-matrixed reporting environment to build strong partnerships.
- Working knowledge of and experience with OnCore®, a clinical trial management system by Forte Research Systems®.
- Experience working with vendors, including both software and consulting services.
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