Clinical Trial Startup Operations Manager – Non-Industry

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 worlds 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 worlds 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 research teams to support Principal Investigators (PIs) and study teams who are focused on mission-critical clinical trials programs. The Clinical Trial Startup Operations Manager Non-Industry will support centralized clinical trial start-up for non-industry studies. Non industry clinical trials include studies sponsored by investigators foundations federal agencies and other non-industry entities.

The incumbent will be responsible for assessing new non-industry oncology clinical trials creating and managing startup plans reviewing requirements and timelines. This position will manage Budget Specialists relative to centralized study startup standard practices and actively partner with clinic implementation regulatory and other functions. This position will develop and continue to refine best practices for a centralized non-industry study startup model. This position will be a subject matter expert for research processes non-industry-sponsored oncology clinical trials and maintain institutional knowledge of startup requirements dependencies site-specific clinic implementation pre and post-award requirements.

Most Fred Hutch jobs requiresomeon-campus work. However there may be flexibility for certain positions. Please check with the recruiter if you are an out-of-state applicant interested only in working outside of the Seattle area.

• Prioritize and proactively implement standardization of startup services to support non-industry clinical trials.
• Oversee Budget Specialists facilitating centralized non-industry startup activities on behalf of study teams.
• Closely partner with protocol writing services & database management services for Investigator InitiatedTrials (IITs) to help ensure operational and financial feasibility considerations are addressed during the protocol development process.
• Manage and oversee operations to ensure continuity with central startup metric goals best practices and standards in support of larger Clinical Research Support strategic initiatives to reduce startup times.
• Review and assess new clinical trial documents to identify and anticipate operational and resource requirements.
• Serve as subject matter expert in identifying research costs reviewing study calendars & billing grids developing and negotiating budgets coordinating contracting processes in accordance with w/protocol and institutional requirements.
• Manage and oversee the preparation and submissions of new non-industry clinical trials to internal financial regulatory and clinical offices.
• Initiate and facilitate meetings with investigators study teams and central office partners in support of centralization timeline reduction workflow and process improvement goals.
• Provide management and oversight of central team source documentation maintenance and record keeping practices throughout the startup process; ensure continuity with CRS standards and best practices for optimal transparency.
• Oversee and optimize weekly startup progress reporting to Investigators study teams internal and external stakeholdersto ensure transparency and accurate expectations throughout the startup process.
• Work closely with Consortium members and study teams to support comprehensive non-industry study startup plan goals and deadlines.
• Work professionally and proactively with central offices clinic partners faculty members and research collaborators in support of the overall research plan.
• Participate in continuing education opportunities to support and advance professional development of project management clinic trial implementation and budget development skills.
• Participate and facilitate process improvement efforts on behalf of the Consortium including implementation of technology solutions and/or workflow improvements.

MINIMUM QUALIFICATIONS:

• Bachelors Degree or equivalent experience.
• 4 years experience in clinical research operations.
• Experience managing oncology clinical trials startup and/or amendment processes including calendar billing grid reviews and budget development & negotiation.
• Demonstrated ability to deliver outcomes in fast paced environments.
• Demonstrated ability to work as an effective member of an interdisciplinary team.
• Demonstrated skills in critical thinking and problem solving.
• Ability to process complex documents and extract key information.
• Working with multi-disciplinary teams.
• Forecasting and meeting deadlines.
• Familiarity with project management tools and techniques.
• Familiarity with CTMS and systems to support workflow & metrics.
• Proficiency in use of Excel MS Word and Acrobat.
• Strong verbal and written communication skills.
• Strong attention to detail and ability to work according to CRS central office standards and best practices.
• Excellent interpersonal skills and ability to build positive and professional working relationships with internal and external stakeholders.
• Effectively able to communicate and demonstrate accountability in a remote setting.

The annual base salary range for this position is from $97552 to $154149 and pay offered will be based on experience and qualifications.

This position may be eligible for relocation assistance.

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).