ImmunOptimize Network Clinical Trials Operations Manager

Overview

Fred Hutchinson Cancer Center is an independent, nonprofit organization providing adult cancer treatment and groundbreaking research focused on cancer and infectious diseases. Based in Seattle, Fred Hutch is the only National Cancer Institute-designated cancer center in Washington.

With a track record of global leadership in bone marrow transplantation, HIV/AIDS prevention, immunotherapy and COVID-19 vaccines, Fred Hutch has earned a reputation as one of the world's leading cancer, infectious disease and biomedical research centers. Fred Hutch operates eight clinical care sites that provide medical oncology, infusion, radiation, proton therapy and related services, and network affiliations with hospitals in five states.

Together, our fully integrated research and clinical care teams seek to discover new cures to the world's deadliest diseases and make life beyond cancer a reality.

At Fred Hutch we value collaboration, compassion, determination, excellence, innovation, integrity and respect. Our mission is directly tied to the humanity, dignity and inherent value of each employee, patient, community member and supporter. Our commitment to learning across our differences and similarities make us stronger. We seek employees who bring different and innovative ways of seeing the world and solving problems.

The Infectious Disease Sciences (IDS) Program of the Vaccine and Infectious Disease Division seeks a versatile and experienced Clinical Trials Operations Manager (CTOM) to serve as a key foundational hire. This individual will manage coordinating center operations, provide site coordination and protocol development support, oversee cross-functional collaboration, and ensure strategic outreach, contributing directly to the development of a nationwide clinical trials Network.

This role spans operational oversight, strategic planning, stakeholder engagement, communications, study implementation, and team building. This position will play a critical role in the initial network infrastructure building efforts to ensure communication, collaboration, staffing and preparedness to launch the initial studies and trials. The role will require working directly with the leading faculty and staff in the Infectious Disease Sciences (IDS) Program in the Vaccine and Infectious Disease Division to ensure the rapid deployment and success of network coordinating center operations.

This position's day-to-day operations focus is being responsible for all facets of the network development activities including overseeing site operations, communicating network support needs with internal departments and external organizations, sponsors and agencies, and interacting effectively with the IDS program teams in research administration, regulatory affairs, program and division senior leadership (scientific and administrative). The position is expected to work independently within a framework of established regulations and guidelines, and demonstrate initiative, capabilities and strengths in addressing problems and advancing outreach efforts.

The CTOM will work under the direction of the Chair of the Scientific Advisory Committee of the Immun Optimize Network and report to the Senior Program Operations Director of IDS/VIDD.

At Fred Hutchinson Cancer Center, all employees are expected to demonstrate a commitment to our values of collaboration, compassion, determination, excellence, innovation, integrity, and respect.

• Manage network operations to support the network's leadership and scientific committees.
• Support the Immun Optimize Network PI(s)/Advisory Committee, and IDS Program leadership in many facets of the network development activities. This includes the development of information/system/website and training materials etc., following up on action items and generating guidance and committee documents.
• Develop and manage network's project charters, timelines, and deliverables on project-specific activities and initiatives.
• Establish relationships with sponsors, advocates, and collaborate with internal and external contacts and stakeholders including communications, marketing, philanthropy, legal, consultants, and vendors, to develop and maintain network documentation and monitor work progress.
• Collaborate with cross-functional teams' input and support regulatory, legal, communications and marketing and grants/contracts teams to ensure timely approvals and results.

• Ensure efficient protocol start-up and implementation at study sites by facilitating and liaising between sites, other functional units with the network, sponsor(s), and others as needed.
• Coordinate development of regular study procedures, protocols, cross-institutional contracts and agreements, regulatory approvals, and trial management.
• Serve as the primary liaison with clinical trial sites; manage and support protocol development efforts for network-wide…