• CTMS Functional Lead

    Job ID
    Regular Full-Time
    Fred Hutchinson Cancer Research Center
    Clinical Research Support Services
  • Overview

    Cures Start Here. At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutch’s pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nation’s first cancer prevention research program, as well as the clinical coordinating center of the Women’s Health Initiative and the international headquarters of the HIV Vaccine Trials Network. Careers Start Here.

    The CTMS Program Office is a tri-institutional office housed within the Fred Hutch Research Administration department providing implementation and operational support services for the OnCore Clinical Trial Management System (CTMS) that is jointly managed by the Fred Hutch, the University of Washington and the Seattle Cancer Care Alliance (SCCA.)

    The CTMS Functional Lead position is a leadership role within the CTMS Implementation team and will be accountable to manage activities and outcomes related to the functional workflow design, testing and workflow documentation for the remainder of the CTMS Implementation. The role will require expert-level analysis skills, project management skills, team and stakeholder management skills. The role will report to the CTMS Project Director and closely collaborate with the technical lead, change management lead and data migration lead to help ensure cross-workstream alignment of functional workflow design with data migration, technology and organizational adoption.


    CTMS Functional Design & Testing

    • Define approach for CTMS detailed functional design, convene stakeholder groups and facilitate design activities
    • Effectively prepare for and facilitate design meetings and presentations with a diverse range of stakeholders including study coordinators, regulatory coordinators, fiscal coordinators, administrative office staff and leadership
    • Develop deep understanding of institutional workflows related to the clinical research administrative offices and study teams
    • Work with SMEs and analysts in related systems such as the Epic EHR system to functionally define, test and implement data flows from the CTMS into Epic
    • Demonstrate expert-level understanding of the capabilities of a CTMS, specifically OnCore from Forte Systems, to enable efficient workflows for research study teams and administrative offices
    • Establish functional testing and user acceptance testing approach and manage testing process
    • Manage functional and workflow analysts who will perform testing activities along with super users.
    • Design highly accurate and comprehensive functional cutover plans, conduct go-live dress rehearsals and perform cutover activities
    • Provide go-live support to end users, and effectively transition functionality from implementation to operations

    Project Management

    • Define detailed workstream-level project plan for the functional workstream outlining design activities, documentation activities, testing and stakeholder engagement activities and deliverables
    • Assign functional workstream tasks, manage workload, inspect workstream deliverables and report workstream status
    • Actively manage workstream level risks and issues escalating as needed to project director


    Cross-Workstream Collaboration

    • Partner with data migration team to define backload strategies that align with future state functional workflows
    • Define and implement plans for pre-go-live data validation of migrated data with study teams and administrative offices
    • Provide clear and concise information to the training team and change management teams to support the development and delivery of training and adoption sessions


    • Bachelor’s Degree
    • Minimum five (5) years of experience in clinical research operations
    • Prior experience implementing OnCore financials at large, complex institutions
    • Experience with IRB systems and workflows is desirable
    • Experience working with CTMS integrations related to the Epic EHR system
    • Knowledge of applicable industry standards and best practices for clinical research
    • Advanced knowledge of business analysis tools, methodologies and best practices; including but not limited to leading cross-functional team discovery and business requirement sessions, process mapping and SWOT analysis
    • Proven ability to lead an implementation workstream serving both as project manager and content expert for the functional workstream
    • Experience with system conversion, customization and integration design and execution
    • Proven ability to communicate complex workflow issues to administrative offices and study team staff
    • Sustained, proven ability to think analytically, problem solve and use independent judgment
    • Excellent communication (written and oral), customer service, collaboration, problem solving and interpersonal skills
    • Superior presentation and organizational skills with an attention to detail mindset
    • Proven ability to work with a diverse group of stakeholders, including technical and non-technical personnel at various levels in the organization
    • Proven ability to teach and train others

    Our Commitment to Diversity

    We are proud to be an Equal Employment Opportunity (EEO) and Vietnam Era Veterans Readjustment Assistance Act (VEVRAA) Employer. We are committed to cultivating a workplace in which diverse perspectives and experiences are welcomed and respected. We do not discriminate on the basis of race, color, religion, creed, ancestry, national origin, sex, age, disability (physical or mental), marital or veteran status, genetic information, 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 escmail@fredhutch.org or by calling 206-667-4700.


    Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
    Share on your newsfeed