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.

The Senior Manager, Clinical Research Operations, leads the standardization and integration of clinical trial workflows, processes, and tools across study teams and operational areas. The incumbent will partner closely with operational leaders to develop and document integrated workflows, define and implement trial portfolio management tools, and lead workgroups to standardize and maintain standard processes. The role will also be responsible for planning and supporting centralization of specific portfolios. The Sr. Manager, Clinical Research Operations, is a position within the central clinical trials office, Clinical Research Support (CRS), and reports to the AVP, Clinical Trial Management.

Responsibilities

• Work across central operational units, including study startup, regulatory, post award, and clinical teams, to map end-to-end workflows, identifying gaps and opportunities for improvement.
• Lead cross-functional workgroups to create, standardize, and harmonize SOPs, tracking tools, and support documents across Consortium study teams.
• With inputs from CRS Compliance and operational leadership, define and support process to assess trial portfolios transitioning to central management; generate resource plan and timelines.
• Serve as central study team resource that is embedded within teams to provide supplemental support during staffing transitions and stabilization periods.
• In partnership with central study team managers and training leads, assess existing tools, SOPs, and documented workflows; create and manage documentation workplan, adjusting priorities as appropriate.
• Work side-by-side with staff across different functions to understand institutional processes, systems, and standards. May perform day-to-day trial management activities for interim periods, as needed.
• Establish standard format for study team and Research Group portfolio reviews; leverage existing dashboards, inform content and design of enhancements and new dashboards. 
• Manage quarterly clinical trial portfolio reviews with Consortium Research Groups including preparation of program summaries and facilitation of portfolio review sessions between CRS leadership and program faculty and research managers.
• Manage workflow design and implementation for targeted process improvements related to clinical trial management.
• Identify, recommend, and as appropriate, implement electronic tools and software to optimize processes.
• Provide regular status updates to CRS leadership on efforts to integrate cross-functional workflows, including improvement barriers and potential solutions.

Qualifications

• Bachelor's degree; master's degree preferred
• 4 years’ experience in the conduct of interventional, treatment, and/or FDA-regulated clinical trials, preferably oncology trials 
• At least 2 years professional experience directly or indirectly managing personnel
• Certified Clinical Research Coordinator (ACRP), Certified Clinical Research Professional (SoCRA), or equivalent certification preferred
• Knowledge of FDA regulations, GCP guidelines, and other applicable federal regulations 
• Experience writing and maintaining SOPs to support clinical research operations
• Experience working with clinical research software systems such as a clinical trial management system (CTMS), electronic regulatory system, and electronic data capture (EDC) systems
• Excellent oral and written communication skills 
• Demonstrated ability to lead and facilitate work across teams
• Excellent interpersonal skills with the ability to build strong relationships with a diverse group of stakeholders 
• Exposure to project management software such as Smartsheet preferred

A statement describing your commitment and contributions toward greater diversity, equity, inclusion, and antiracism in your career or that will be made through your work at Fred Hutch is requested of all finalists.

The annual base salary range for this position is from $106,427 to $168,223 and pay offered will be based on experience and qualifications. This position may be eligible for a sign on bonus.

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), paid parental leave (up to 4 weeks), and partially paid sabbatical leave (up to 6 months).

Our Commitment to Diversity

We are proud to be an Equal Employment Opportunity (EEO) and Vietnam Era Veterans Readjustment Assistance Act (VEVRAA) Employer. We are committed to cultivating a workplace in which diverse perspectives and experiences are welcomed and respected. We do not discriminate on the basis of race, color, religion, creed, ancestry, national origin, sex, age, disability (physical or mental), marital or veteran status, genetic information, sexual orientation, gender identity, political ideology, or membership in any other legally protected class. We are an Affirmative Action employer. We encourage individuals with diverse backgrounds to apply and desire priority referrals of protected veterans. If due to a disability you need assistance/and or a reasonable accommodation during the application or recruiting process, please send a request to our Employee Services Center at hrops@fredhutch.org or by calling 206-667-4700.