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 Hutchs 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 nations first cancer prevention research program, as well as the clinical coordinating center of the Womens 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
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
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
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
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At Fred Hutchinson Cancer Research Center, teams of world-renowned scientists and humanitarians work together to prevent, diagnose and treat cancer, HIV/AIDS and other diseases. Researchers are discovering new ways to detect cancers earlier, improve treatments, and learn how to prevent cancers from growing. Although Fred Hutchinson opened its doors in 1975, its history began about 20 years before that. In 1962 Fred Hutchinson envisioned a center devoted to studying cancer, a disease that took his brother’s life. Today Fred Hutchinson is contributing to the next waves of breakthrough treatments and prevention strategies. Fred Hutchinson collaborates with the Seattle Cancer Alliance, the National Cancer Institute, and the University of Washington.