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||Fred Hutchinson Cancer Research Center
||Seattle, WA S
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CTMS Program Office Director|
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:
Generating new scientific discoveries and translating them into effective medical practices, therapies and public health approaches
Recruiting, supporting and training highly qualified scientists and physicians in an environment that promotes collaboration and excellence
Cooperating with other research entities and medical institutions to assure worldwide access to new research findings and technical developments
Providing sensitive, efficient and effective care for patients participating in our experimental therapies and other studies
Promoting the importance of scientific research, responsible medical care, healthy environments and personal behaviors through public education and advocacy.
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>
Lead the development and establishment of CTMS Program operational standards and service level agreements. Direct CTMS Program activities and coordination with institutional partners to meet operational standards, service level agreements, and to achieve the goals of the CTMS Program.
Maintain accountability and effective communications to partner institutions and stakeholders.
Ensure user adherence to CTMS Program policies; escalates issues to tri-institutional partner stakeholders as appropriate.
Maintain close working relationships with institutional leaders and user groups collaborators across partner institutions to ensure that system support is meeting all requirements and that any system or requirement changes are planned appropriately.
Inform CTMS Program strategy and direction through CTMS metrics and reports to stakeholders; solicit regular feedback from stakeholders.
Collect and report metrics to ensure high quality, timely, professional support that meets or exceeds service level agreements.
Direct the CTMS Program in accordance with the governance plan; includes managing relationships with CTMS stakeholders, convening and driving sponsor meetings, and maintaining effective program decision and communication practices.
Deliver CTMS Program implementation and operational transition on time and on budget. Participate in the development of the CTMS Program Office budget and manage the Office within budget. Prepare and provide regularly scheduled CTMS Program financial reporting to CTMS Executive Sponsors and institutional stakeholders.
Assess and plan resource needs based on CTMS Program volume trends and communicate projected needs to CTMS Executive Sponsors as part of ongoing budget reports.
Identify areas of data discrepancies and CTMS Program operation inefficiencies; recommend policy, training and remediation strategies to stakeholders.
Continuously evaluate the requirements and needs from the CTMS Program, and provide recommendations of beneficial changes to CTMS Executive Sponsors.
Support the development of, maintain, and disseminate policies and procedures that govern the utilization of the CTMS by faculty, research staff, clinic staff, and administration across the three institutions including oncology and non-oncology CTMS users.
Collaborate with institutional partner operational leads to define CTMS Program issues that require escalation, and propose and present solutions to institutional Executive Sponsors.
Convene CTMS governance meetings and facilitate decision-making, provide progress on strategic priorities, user adoption and experience, status updates, operational performance, etc.
CTMS Program Implementation and Operational Transition – <More % FTE initially, decreasing to 0% at full operations>
Direct project management resources to support the multi-year CTMS Program implementation across institutions; includes oncology and non-oncology research, and the compliant integration with existing institutional systems, including clinical billing systems.
Collaborate with institutional IT departments in the planning for system interfaces, testing, and updates.
Oversee the CTMS Program implementation and planning through active participation in and under the direction of CTMS Program governance.
Direct the development and operationalization of the CTMS Program Office and resource plan.
Direct data migration need assessments, planning, and execution driven by CTMS Program changes.
Oversee and be accountable for a successful transition from CTMS system implementation to operations and maintenance; includes oversight of project managers and teams responsible for change management and stakeholder communication.
Ensure comprehensive support functions, including user onboarding and training, and technical system support.
CTMS Program Office Management – <Less % FTE initially, increasing to 60% at full operations>
Design, establish, and manage CTMS Program Office organizational structure and staffing to achieve the goals and objectives for all phases of implementation and ongoing operations.
Collaborate with UW Medicine ITS and the CTMS application vendor to maintain working systems, resolve technical issues and implement system upgrades; collaborate with FHCRC and SCCA IT departments as needed. Oversee the management of a central CTMS master pricing table representing services provided by multiple clinical partners.
Support and coordinate with institutional partners, study start-up and management activities occurring through the CTMS: protocol data entry and calendar creation, pre-budget procedure coding, coverage analysis, budget development, sponsor negotiation, subject visit tracking, and sponsor invoicing.
Participate in the development of service level expectations, and assure these expectations are achieved for oncology and non-oncology clinical trials.
Manage CTMS Program resources according to approved budget and identify strategies for creating efficiencies in operations.
Enforce data and service quality controls and standards for system utilization and data management.
Responsible for recruitment, training, motivating and performance management of CTMS Program Office staff.
Develop and mentor staff based on goals, accountability, objectives, and priorities.
Effectively collaborate with tri-institutional peers (such as the Cancer Consortium and University of Washington Clinical Trial Offices and relevant sites of practice at SCCA and the University of Washington Medical Center) to support the supervision of external staff in the performance of CTMS Program-related functions.
Provide CTMS functional direction and supervision for technical system management staff in support of the CTMS application and technologies.
Utilize contract resources when appropriate.
PEER AND PARTNER RELATIONSHIPS
Work with stakeholders within the tri-institutional partnership to assure that reporting data requirements are met and that the CTMS Program and collaborators adhere to the necessary data governance structure.
Team with the Director for Research IT, or other UW Medicine ITS designate, for the technical management and support of the CTMS. Work in partnership to plan for technical maintenance and upgrades, and assure communication of technical schedules to relevant stakeholder. Escalate technical risks to CTMS Executive Sponsor Committee that cannot be resolved due to prioritization concerns.
Collaborate with peers in the tri-institutional partnership to develop and establish CTMS user onboarding and training. Assure the consistent and standardized utilization of the CTMS across the partnership.
Work with institutional stakeholders to develop annual budgets and to strategize the allocation of resources within CTMS Program operations.
Identify new opportunities to leverage CTMS data across the institutions to improve transparency, efficiency, and compliance in clinical research-related operations.
Initiate and participate in CTMS-related collaborative efforts to achieve efficient intersection of institutional process with relevant CTMS-processes, and to merge data across various systems and departments among the tri-institutional partnership.
- 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 an IT system in the administration of 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.
- Recognized ability to navigate and successfully lead the management of changes introduced by new technologies and processes.
- Understanding of research administration lifecycle processes, including but not limited to: clinical research coverage analysis, budget development, research revenue cycle functionality, and general billing compliance.
- Knowledge of state and federal regulations governing clinical research; includes the application of Medicare Clinical Trials Policies 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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We are committed to cultivating a workplace in which diverse perspectives and experiences are welcomed and respected. We are proud to be an Equal Opportunity and VEVRAA Employer. We do not discriminate on the basis of race, color, religion, creed, ancestry, national origin, sex, age, disability, marital or veteran status, sexual orientation, gender identity, political ideology, or membership in any other legally protected class. We are an Affirmative Action employer. We encourage individuals with diverse backgrounds to apply and desire priority referrals of protected veterans. If due to a disability you need assistance/and or a reasonable accommodation during the application or recruiting process, please send a request to our Employee Services Center at firstname.lastname@example.org or by calling 206-667-4700.
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