Senior Manager, Clinical Research Operations

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. These values are grounded in and expressed through the principles of diversity, equity and inclusion. 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. Fred Hutch is in pursuit of becoming an anti-racist organization. We are committed to ensuring that all candidates hired share our commitment to diversity, anti-racism and inclusion.

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. 

The Senior Manager, Clinical Research Operations is primarily responsible for setting vision and executing scalable & sustainable research management practices for designated research programs in our oncology clinical trials portfolio. The trial portfolios include multi-site investigator-initiated IND trials, industry trials, and single-site investigator-initiated trials.  Reporting to the Assistant Director of Clinical Trials Coordination, the role will oversee a clinical research team within Medical Oncology which includes Breast Oncology, Genitourinary Medical Oncology, Gastrointestinal Oncology and other specialized  Oncology Programs.

Responsibilities

• Set vision and strategy for building and managing research teams that can effectively deliver on research program goals.
• For designated research programs:
• Assess protocol feasibility and advise program leadership and PIs on clinical trial protocol development and selection
• Oversee the study startup process partnering closely with the central startup team
• Oversee implementation of research protocols through the entire life cycle of a study from feasibility assessment to closeout
• Oversee protocol related activities of designated research staff including clinical research coordinators, data coordinators, reg coordinators, research team nurses
• Develop and maintain close relationships with internal and external partners
• Develop and maintain standard operating procedures (SOPs) for each program, aiming for standardization wherever possible across programs
• Understand total costs and effort related to each study and actively manage study budget through the lifecycle of a study
• Define administrative direction and implementation of research management functions, best practices, policies and SOPs to meet the needs of multiple disease groups/research programs.
• Foster collaboration and clear engagement models between research management functions, CRC functions, data coordination functions, research nursing functions and clinic operations functions.
• Form and execute plan to staff growing team by developing staff and offering professional growth opportunities.
• Compile and evaluate research resource utilization and allocation.
• Identify Consortium and program improvement opportunities and lead improvement efforts within team, including technology solutions; identify opportunities for expanding solutions to Consortium study teams.
• Make recommendations to leadership and oversee changes in operations as necessary. Develop systems for continuous monitoring.
• Define and report-out program metrics and key performance indicators for UW and FH department/division, institutional and Consortium leadership, and faculty.

Qualifications

MINIMUM QUALIFICATIONS:

• Bachelor's degree/equivalent qualification or experience 
• 7 years of experience as project or program manager in clinical research or equivalent
• Excellent interper