Clinical Trials Fiscal Program Manager

Fred Hutchinson Cancer Center•Seattle, WA

About The Position

The Clinical Trials Fiscal Program Manager prepares, negotiates, administers, and maintains clinical trial budgets in accordance with study protocols, coordinating research-related financial activities with clinical trial implementation and research teams. The role ensures accurate budgets and contracts, reconciles expenditures throughout each protocol lifecycle, and manages the financial sustainability of an assigned portfolio of clinical trials. It also establishes and maintains professional relationships with sponsors and regulatory agencies. The position leads quality control, standardization, and staff development for clinical trial calendar review, billing-grid review, and related fiscal activities. It performs hands-on startup work and maintains SOPs, work instructions, job aids, and targeted training. The manager sets quality standards, conducts routine and risk-based reviews, identifies deficiencies and financial or billing risks, develops corrective action plans, and turns recurring findings into standardized tools, guidance, and training. The manager oversees trial financial management, including payment schedules, billing, budgets, sponsor collections, portfolio reporting, and forecasting. The role works with Fred Hutch Finance, Clinical Research Support, and other stakeholders to support clinical trial accounting policies and resolve financial or operational issues before study activation.

Requirements

Bachelor's degree in finance, accounting, or a related field, or equivalent qualification or experience.
At least 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.
Strong organization, attention to detail, and time-management skills to manage multiple competing demands.
Effective and professional oral and written communication skills.
Advanced skills with detailed financial analysis tools and reporting.
Strong computer skills, including Microsoft Word, Excel, Access, and Adobe Acrobat; advanced Excel knowledge is required.

Nice To Haves

Clinical research-related certification.
Experience with clinical trial management systems (CTMS).
Experience working in Epic.
Ability to use a wide variety of software packages for research management.

Responsibilities

Build and negotiate clinical trial budgets, including industry-sponsored and investigator-initiated trial budgets.
Work with study principal investigators to estimate proposed investigator-initiated trial costs and 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 in the clinical trial management system, including visit structure, procedure timing, conditional events, cycles, optional procedures, follow-up, end-of-treatment, survival follow-up, and amendment changes.
Develop and maintain calendar-review checklists, naming conventions, documentation expectations, and escalation pathways.
Partner with CTMS, research operations, billing compliance, and informatics teams to address system design, workflow, and data-integrity issues.
Verify that billing-grid determinations are supported by the protocol, study design, informed consent form, sponsor obligations, clinical trial agreement, coverage requirements, and institutional policy.
Conduct comprehensive quality reviews of industry-sponsored clinical trial budgets before submission, negotiation, finalization, and amendment execution.
Confirm budgets include protocol-required activities and institutional resource needs, and that budget line items align with the approved calendar and billing grid.
Assess budget assumptions for completeness, consistency, cost recovery, financial sustainability, sponsor payment timing, and adequate reimbursement for institutional work.
Ensure financial terms align with the clinical trial agreement, payment schedule, invoicing triggers, payment milestones, pass-through treatment, and sponsor or CRO requirements.
Identify missing budget items, inadequate payment terms, unsupported assumptions, financial concessions, and study-specific risks requiring attention.
Ensure clinical trial legal contracts conform to informed consent documents and that payment terms are favorable to the institution.
Assess downstream post-award implications and engage stakeholders to identify, resolve, and mitigate financial or operational issues before study activation.
Design, implement, and maintain training and competency programs for staff performing calendar reviews, 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 training resources such as SOPs, work instructions, checklists, templates, de-identified case studies, documentation standards, and escalation criteria.
Partner with the supervisor to provide individualized coaching and feedback based on QC findings, quality metrics, recurring errors, workload complexity, and 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 creating and maintaining systems to track payment schedules, billing, and budgets.
Monitor sponsor invoice payments and follow up directly with sponsors to collect overdue funds; work with the Office of General Counsel when collection efforts are unsuccessful.
Develop and manage portfolio reporting, including revenue-versus-expense calculations for individual trials, projections, and study-team operations.
Track and forecast the study portfolio.
Work with Fred Hutch Finance and Clinical Research Support to support clinical trial accounting policies and procedures.