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 Startup Operations Manager is responsible for managing centralized clinical trial startup in Fred Hutch and Fred Hutch/University of Washington Cancer Consortium’s clinical trials office, Clinical Research Support (CRS). The incumbent will be responsible for assessing the operational logistics of new industry-sponsored oncology clinical trials, facilitating financial pre-authorization discussions on behalf of research groups and central startup with internal and external stakeholders. This position will also manage and oversee standardization of oncology industry budgets, REDCap, CTMS processes and workflows owned by CRSstartup. This position provides an opportunity for increased standardization and financial feasibility while continuing to increase volumes of clinical trials and reduce startup times.

This position will support oversight of CRS Startup Team leads, training and quality control processes relative to central study startup standards and practices, budget negotiation and clinic implementation in support of larger CRS strategic goals initiatives. This position will also work with industry sponsors, internal/external regulatory and financial specialists, to lead change management across Consortium study teams in support of increased central startup utilization. The Senior Startup Operations Manager will partner with CRS leadership to maintain business and faculty relationships and communications.

This position will develop and continue to refine best practices for a centralized study startup model. This position will be a subject matter expert for research budget negotiations, research processes, industry-sponsored oncology clinical trials, and maintain institutional knowledge of startup requirements, dependencies, site-specific clinic implementation, pre and post-award requirements.

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.

Responsibilities

• Develops and manages REDCap/CTMS workflows required for financial standardization of oncology clinical trials.
• Prioritizes and proactively facilitates negotiation discussions with industry partners.
• Implements standards for industry-sponsored budget negotiations to increase the financially viability of research groups and maximize continuity with cancer centers nationwide.
• Supports Asst Director oversight of Central Startup Team facilitating centralized startup activities on behalf of study teams.
• Implements Consortium best practices for clinic implementation and budget negotiations; support development and maintenance of CRS published resources to support clinical trial startup initiatives and broader strategic goals.
• Assesses clinical trial documents to identify and anticipate operational and resource requirements.
• Serves as a subject matter expert in identifying research costs, developing comprehensive budgets and maximizing negotiation of industry sponsored clinical trials in accordance with protocol and institutional requirements (i.e. institutional fees, procedure and administrative costs, study team time and effort, etc.)
• Maintains current understanding of study start-up operations, timelines, and budgeting trends in clinical research; make recommendations to Asst Director of Clinical Trial Startup.
• Participates in continuing education opportunities to support and advance professional development of project management, clinic trial implementation and budget development skills.
• Participates and facilitates process improvement efforts on behalf of the Consortium including implementation of technology solutions and/or workflow improvements.

SCOPE OF RESPONSIBILITY:

• Manages and oversees industry submissions for clinical trials in parallel with internal financial and clinical offices.
• Manages and oversees meetings with industry sponsors, study teams and central office partners in support of centralization, timeline reduction, workflow, and process improvement goals.
• Manages and oversees central team source documentation maintenance and record keeping practices throughout the start-up process; ensure continuity with CRS standards and best practices for optimal transparency.
• Oversees and optimizes status update reporting to industry sponsors, Investigators, and study teams to ensure transparency and accurate expectations throughout the start-up process.
• Works with Asst Director of Clinical Trial Startup to ensure process continuity, transparency, and efficiency in support of consortium startup metrics; determine and improve operational process standards based on feedback and data from internal and external partners.
• Works with Consortium members and study teams to support financial standardization, portfolio prioritization and startup planning.
• Works professionally and proactively with central offices, clinic partners, faculty members and research collaborators in support of the overall research plan.

Qualifications

Minimum Qualifications:

• Bachelor's degree and 6 years of experience
• Starting and managing oncology clinical trials
• Mentoring/training staff and/or teams
• Working across different academic institutions to facilitate research projects
• Working with multi-disciplinary teams
• Preparing, negotiating and managing industry sponsor clinical trial budgets
• Forecasting and meeting deadlines
• Communicating with all levels of a research organization
• Team building and management
• Clinical research related certification preferred
• Strong verbal and written communication skills
• Knowledge of applicable local, state and federal regulations and guidelines

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 $104,416 to $165,006 and pay offered will be based on experience and qualifications.

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 Human Resources at hrops@fredhutch.org or by calling 206-667-4700.