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 Study Financial Management Adoption Lead is a leadership role within the CTMS Implementation team and will be accountable to manage activities and outcomes related to process improvement, change management, operational readiness, and adoption related to the remainder of the CTMS Implementation. The role will require expert-level analysis skills, expert-level understanding of clinical research administration workflows, project management skills, team and stakeholder management skills. The role will report to the CTMS Project Director and closely collaborate with the functional lead, technical lead, change management lead and data migration lead to help ensure cross-workstream alignment of change management and adoption with functional design, data migration, and technology.
Process Analysis & Improvement
Actively engage study teams and research administration central offices to understand study financial management workflow pain points and identify improvement opportunities that can be introduced as part of a CTMS implementation.
Demonstrate expert-level understanding of workflow best practices for study budget management, coverage analysis, coding/pricing, subject visit tracking and sponsor invoicing and champion the alignment of institutional practices with best practices where applicable
Develop deep understanding of institutional workflows related to the clinical research administrative offices and study teams
Effectively prepare for and facilitate workflow assessment meetings and presentations with a diverse range of stakeholders including study coordinators, regulatory coordinators, fiscal coordinators, administrative offices staff and leadership
Engage closely in functional design session planning, facilitation and follow-up to help ensure pain points and improvement opportunities are being appropriately addressed during CTMS design
Change Management, Communication & Training
Define overall change management strategy and plan including training approach, communication approach, operational cutover approach and adoption approach
Define training plan for onboarding administrative offices and study teams to new CTMS workflows; oversee development of training materials and training execution
Define communication strategy and partner closely with communications lead on execution
Execute change management strategy including leading roadshows, brown bags, adoption sessions, demos, and other forums that help champion the CTMS to a diverse set of stakeholders
Define and manage the change management governance structure including super user working groups, change champion networks and other such bodies
Define detailed workstream-level project plan for the adoption/change management workstream outlining workflow analysis activities, communication activities, training activities, documentation activities, stakeholder engagement activities, operational cutover activities and deliverables
Assign adoption/change management workstream tasks to project team members, and manage progress to completion
Actively manage workstream level risks and issues escalating as needed to project director
Minimum five (5) years of experience in clinical research operations
Prior experience with study financial management process improvement at large, complex institutions
Experience working with CTMS, preferably OnCore from Forte systems
Knowledge of applicable industry standards and best practices for clinical research
Advanced knowledge of business analysis tools, methodologies and best practices
Proven ability to lead an implementation workstream serving both as project manager and content expert for the change management/adoption workstream
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.