GU Senior Clinical Research Manager

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.

We are actively expanding our central team to support Principal Investigators (PIs) and research study teams who are focused on mission-critical clinical trials programs across the Fred Hutch, University of Washington, and Seattle Children's Cancer Consortium ("Cancer Consortium").

The Genitourinary (GU) Senior Manager, Clinical Research Operations is primarily responsible for setting vision and executing scalable and sustainable research management practices for the GU oncology clinical trial portfolio. The trial portfolios include phase I-IV therapeutic, multi-site industry trials, investigator-initiated trials, and national cooperative group trials. The Sr. Manager is a member of the Cancer Consortium's central clinical trials office, Clinical Research Support (CRS), and reports to the Senior Director of Clinical Trial Coordination.

Set vision and strategy for building and managing research teams that can effectively deliver on research program goals.
• Advise program leadership and principal investigators on protocol development and selection by assessing clinical trial feasibility.
• Partner with central startup teams to ensure timely and efficient study activation.
• Oversee the full study lifecycle, from feasibility assessment and startup through implementation and closeout.
• Manage/Supervise protocol-related activities of designated research staff, including clinical research coordinators, data coordinators, regulatory coordinators, and research nurses, ensuring alignment with study requirements and institutional standards.
• Build and sustain strong partnerships across internal departments and external sponsors, CROs, and sites to ensure alignment and efficiency in clinical research operations.
• Lead the implementation of SOPs, ensuring all team members are trained and operate in full compliance with Clinical Trial Coordination (CTC) and institutional standards.
• Understand total costs and effort related to each study and actively manage study budget through the lifecycle of a study
• Drive cross-functional alignment by defining and fostering effective collaboration models among research, clinical, and operational teams. Execute a staffing plan that ensures appropriate team capacity and effective use of available resources.
• Identify challenges and improvement opportunities within CTC; lead team-based solutions, including technology enhancements, and expand successful initiatives to broader CRS study teams.
• Define and report-out program metrics and key performance indicators for UW and FH department/division, institutional and Consortium leadership, and faculty.
• Lead performance management activities, including providing regular feedback, conducting annual evaluations, and supporting professional development in alignment with HR policies and organizational goals.
• Other duties as assigned

MINIMUM QUALIFICATIONS:

• Bachelor's degree/equivalent qualification or experience
• 7 years of experience as project or program manager in clinical research or equivalent
• Experience working with EHR systems.
• Experience working with clinical trial management systems.
• Experience working with project management software.
• Excellent leadership abilities.
• Excellent computer skills including ability to use wide variety of software packages for research data management and visualization.
• Excellent interpersonal skills with the ability to build strong relationships with a diverse group of stakeholders.
• Excellent oral and written communication skills.

PREFERRED QUALIFICATIONS:

• Advanced degree preferred (i.e. MBA, MHA, MPH, etc.).
• Clinical research-related certification.
• Project Management (PMP) certification.
• Experience with Tableau or other data visualization tools.
• Knowledge of FDA regulations, GCP guidelines, and other applicable federal regulations
• 5 years' experience as a coordinator or in a related role in the conduct of interventional, treatment, and/or FDA-regulated clinical trials, preferably oncology trials
• 2 years professional experience managing teams. Strong leadership skills are required to lead clinical resources through periods of growth, change and time pressure. The ideal candidate will have a demonstrated ability to:
  • manage a diverse team, think creatively and globally, project future needs, and be attuned to the day-to-day division operations
  • effectively lead individual teams as well as act collaboratively across an organization
• Demonstrated track record of hiring, training, and mentoring a team of clinical research coordinators

The annual base salary range for this position is from $115,170 to $182,020, and pay offered will be based on experience and qualifications.

This position may be eligible for relocation assistance.

This position may be eligible for sign on bonus.

This position is not eligible for H1-B sponsorship at this time.

Fred Hutchinson Cancer Center offers employees a comprehensive benefits package designed to enhance health, well-being, and financial security. Benefits include medical/vision, dental, flexible spending accounts, life, disability, retirement, family life support, employee assistance program, onsite health clinic, tuition reimbursement, paid vacation (12-22 days per year), paid sick leave (12-25 days per year), paid holidays (13 days per year), and paid parental leave (up to 4 weeks).