Clinical Trial Fiscal Program Manager

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. 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.

The Clinical Trial Fiscal Program Manager prepares, negotiates, administers, and maintains study budgets in accordance with the study protocol and works with the clinical trial implementation and research teams to coordinate all research related financial activities associated with clinical trial protocols.  Assures accuracy of study budgets and contracts and reconciles study expenditures throughout protocol lifecycle ensuring that studies are financially sustainable.  Establishes and maintains professional relationship with study sponsors and regulatory agencies.  Accountable for all financial aspects of an assigned portfolio of clinical trials ensuring appropriate management of all trial budgets throughout the lifetime of the study.  The role also leads quality-control, standardization, and staff-development activities for clinical trial calendar review, billing grid review, and . This role is responsible for performing hands on startup work and maintaining comprehensive SOPs, Work Instructions, Job Aids, At-the-Elbow training, and targeted training based on quality trends.  The Manager establishes clear quality standards; conducts risk-based and routine QC reviews; identifies deficiencies and financial or billing risks; develops corrective action plans; and converts recurring findings into standardized tools, guidance, and training.

Responsibilities

• Build and negotiate clinical trial budgets, including industry and investigator-initiated trial (IIT) budgets. Working closely with the study PI, create accurate estimates of the cost of proposed IITs to secure pharmaceutical trial funding.
• Provide subject-matter support for complex protocol interpretation, high-risk studies, difficult sponsor negotiations, novel treatment modalities, and amendments with material financial impact
• Lead quality-control review of clinical trial calendars built in the clinical trial management system (CTMS), including visit structure, procedure timing, conditional events, cycles, optional procedures, follow-up, end-of-treatment, survival follow-up, and amendment-related changes.
  • Develop and maintain calendar-review checklists, standardized naming conventions, documentation expectations, and escalation pathways.
  • Partner with CTMS, research operations, billing compliance, and informatics teams to address system design issues, workflow gaps, and data-integrity concerns.
• Verify that billing-grid determinations are supported by the protocol, study design, informed consent form, sponsor obligations, clinical trial agreement, applicable coverage requirements, and institutional policy.
• Conduct comprehensive quality reviews of industry-sponsored clinical trial budgets before submission, negotiation, finalization, and amendment execution.
  • Confirm that the budget captures all protocol-required activities and institutional resource needs.
  • Validate that budget line items align with the approved calendar and billing grid.
  • Assess budget assumptions for completeness, internal consistency, cost recovery, financial sustainability, sponsor payment timing, and adequacy of reimbursement for required institutional work.
  • Ensure financial terms are consistent with the clinical trial agreement, payment schedule, invoicing triggers, payment milestones, pass-through treatment, and sponsor/CRO requirements.
  • Identify missing budget items, inadequate payment terms, unsupported assumptions, financial concessions, or study-specific risks requiring
  • Ensure all clinical trial legal contracts conform to the Informed Consent Documents and ensure that payment terms are favorable to the Institution.
  • Assess study budgets for downstream post-award implications and proactively engage relevant stakeholders to identify, resolve, and mitigate financial or operational issues prior to study activation.
• Design, implement, and maintain a structured training and competency program for staff responsible for calendar review, CTMS builds, billing grid reviews, industry budgets, amendments, and related clinical trial finance activities.
• Create advanced training for complex studies, including oncology, early-phase, cellular therapy, device, imaging-intensive, pharmacokinetic, biospecimen-heavy, and amendment-intensive trials.
• Develop practical training resources, including Standard operating procedures and work instructions, check lists, & templates, Case studies based on de-identified quality findings, Documentation standards and escalation criteria.
• In partnership with the supervisor, provide individualized coaching and feedback based on QC findings, quality metrics, recurring errors, workload complexity, and staff development needs.
• Analyze QC findings to identify root causes, recurring defects, process variation, training needs, workflow bottlenecks, and technology opportunities.
• Direct financial management of ongoing clinical trials, including creation and maintenance of financial systems to track payment schedules, billing, and budget management.
• Monitor status of sponsor invoice payments and when payments are overdue, follow up directly with the sponsor for collection of funds owed. If unable to collect from sponsor, work with the Office of General Counsel on case.
• Develop and manage comprehensive portfolio reporting, including overall revenue versus expenses calculations of individual clinical trials, projections, and study team operations. Track and forecast study portfolio.
• Work closely with Fred Hutch Finance and Clinical Research Support to support clinical trials accounting policies and procedures.

Qualifications

MINIMUM QUALIFICATIONS:

• Bachelor's degree in finance/accounting or related field or equivalent qualification or experience.
• Minimum seven years of experience in fiscal management of Phase I-III clinical trials
• Demonstrated ability to work effectively in a fast-paced financial management environment.
• Highly organized and detail oriented with strong time management skills to effectively manage multiple and competing demands.
• Effective and professional oral and written communication skills required.
• Advanced skills with detailed financial analysis tools and reporting.
• Strong computer skills—MS Word, Excel, Access, Adobe Acrobat and advanced knowledge of Excel required.

PREFERRED QUALIFICATIONS:

• Clinical research-related certification preferred.
• Experience with Clinical Trial Management Systems (CTMS) preferred.
• Experience working in Epic preferred.
• Excellent computer skills including ability to use wide variety of software packages for research management.

The annual base salary range for this position is from $107,079 to $169,228, and pay offered will be based on experience and qualifications.Although Fred Hutch is not sponsoring most H-1B visas at this time, candidates who already hold an H-1B sponsored by another organization and are currently in the U.S. may be eligible for this position.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), and paid parental leave (up to 4 weeks).

Additional Information

We are proud to be an Equal Employment Opportunity (EEO) and Vietnam Era Veterans Readjustment Assistance Act (VEVRAA) Employer. 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 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 [email protected] or by calling 206-667-4700.