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, Startup Portfolio Management, is responsible for managing pre-pipeline activities, standardization initiatives and integrated project/portfolio management related to clinical trial startup and amendments implemented at the main campus and Fred Hutch Community Sites. This position will manage the implementation and sustainment of standardization initiatives & end to end project management of study startup and amendments. This position will work with sponsors, internal/external clinic areas, and study teams on initiatives to decrease startup timelines. This position will report to the Sr. Director, Clinical Trial Startup & Amendments.

Most Fred Hutch jobs require some on-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.

Responsibilities

• Lead implementation and sustainment of standardization initiatives such to help decrease study startup timelines.
• Accountable for end-to-end project management of study startup & amendments.
  • Oversee 5+ operations specialists and 2 project managers who will be responsible for Intake to OTA timeline management for new studies, and Submission to Implementation timeline management for amendments.
  • Develop and foster deep expertise within the Ops Specialist/PM team on study startup workflows and drive operational implementation of trials; actively track required financial, regulatory & clinic tasks, timelines and issues, escalating as necessary to maintain timelines.
  • Continually deepen team expertise on assessment of clinical trial documents to identify and anticipate operational requirements, and resolve barriers
  • Develop standard tools for tracking & reporting on project and pipeline status.
  • Oversee and optimize status update reporting to industry sponsors, Investigators, and study teams to ensure transparency and accurate expectations throughout the start-up process.
  • Actively partner with leads for each startup function (finance, reg, clinic, orders) to identify and resolve cross-functional issues.
  • Tag study specific issues that need to be addressed on a systemic level & drive improvement projects.
  • Partner with data analytics team to enhance REDCap/CTMS/Zendesk/SmartSheet/Tableau/Reporting tools required for standardization of oncology clinical trial startup & amendments.
• Drive continuing education opportunities to support and advance professional development of project management, clinic trial implementation, & financial startup skills.
• Manage and oversee meetings with industry sponsors, study teams and central office partners in support of centralization, timeline reduction, workflow, and process improvement goals.
• Work with Consortium members and study teams to support standardization, portfolio prioritization and startup planning.
• Work professionally and proactively with central offices, clinic partners, faculty members and research collaborators in support of the overall research plan.
• Maintain current understanding of study start-up operations, timelines, and startup workflow trends in clinical research.

Qualifications

MINIMUM QUALIFICATIONS:

• Bachelor's degree
• 5 years of experience in clinical research operations
• Experience managing startup and amendment workflows, and managing staff who perform startup activity.
• Experience working in multi-disciplinary teams
• Hands on experience identifying & facilitating solutions for clinic implementation barriers
• Designing & implementing process improvements across study startup & amendments
• Knowledge of applicable local, state and federal regulations and guidelines for clinical research
• Mentoring/training staff and/or teams
• Forecasting and meeting deadlines
• Communicating with all levels of a research organization
• Team building and management
• Strong verbal and written communication skills

PREFERRED QUALIFICATIONS:

• Master's Degree
• Clinical research related certification 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 $104,416 to $165,006, 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