Research Manager, Central Regulatory 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.

 

The Regulatory Operations Manager leads a team of regulatory coordinators and regulatory assistants within the Fred Hutch and Fred Hutch/University of Washington Cancer Consortium’s central clinical trials office, Clinical Research Support (CRS). The operations manager is responsible for the planning and execution of regulatory oversight for the Breast Medical Oncology, Global Oncology, and other specialized Oncology clinical research portfolios. The portfolio includes investigator-initiated trials, multi-site IND trials and industry-sponsored trials.

Responsibilities

• Oversee day-to-day operations of a central team that is responsible for managing regulatory submissions and maintaining all regulatory files for designated clinical research portfolios ensuring quality, timeliness and compliance with applicable policy and regulations.
• Collaboratively develop vision and strategy for building and managing a regulatory team that can effectively support the research program goals.  
• Oversee the hiring and resource planning within the Central Regulatory team to align with the size, complexity, and growth of trial portfolios.
• Develop and maintain standard operating procedures (SOPs), and ensure staff adherence to SOPs through training, oversight, and QC of team’s work.
• Establish a close working relationship with study managers, PIs, and other key program personnel to maintain defined processes, and roles and responsibilities across teams and operational areas.
• Form strong partnerships with disease group faculty and administrative leaders, developing standard report-outs for each research program’s portfolio.
• Utilize central systems, tracking tools, and dashboards to manage workload, performance, and capacity.
• Identify opportunities for operational improvements, make recommendations to leadership, and oversee changes as necessary. Develop systems for continuous monitoring.
• Form and execute plans to staff a growing team by developing staff and offering professional growth opportunities.
• Work collaboratively with fellow Research Managers create and execute on a vision for Central Regulatory growth and influence.
• Track and report-out team metrics and key performance indicators to department and research program leadership.

Qualifications

• Bachelor's degree/equivalent qualification or experience 
• 3 years’ experience managing regulatory documentation. Experience managing oncology industry-sponsored and investigator-initiated trials preferred.
• At least 2 years’ experience directly or indirectly managing personnel and training team members.
• Regulatory related certification preferred.   
• Knowledge of FDA regulations, GCP guidelines, and other applicable regulations 
• Excellent interpersonal skills with the ability to build strong relationships with a diverse group of stakeholders. 
• Strong attention to detail and ability to work according to Standard Operating Procedures (SOPs)
• Experience working with a clinical trial management system (CTMS), and electronic regulatory binder system preferred. 
• Excellent oral and written communication skills 
• This is a majority remote position suppo