Clinical Trial Startup Project Manager

Fred Hutchinson Cancer Center•Seattle, WA

About The Position

Fred Hutchinson Cancer Center is seeking a Clinical Trial Implementation Project Manager for its Clinical Readiness Team within the Clinical Research Support Department. The role manages clinic implementation activities for clinical trials, identifying and resolving implementation gaps and issues so trials can open to enrollment. After a trial opens, the project manager continues to manage implementation of amendments through the study lifecycle. The position also supports portfolio management for more than 100 active clinical trial submissions, training, and process improvement. The project manager tracks a portfolio of 20 or more high-complexity trials, establishes goals and timelines, maintains project plans and issue trackers, coordinates multidisciplinary stakeholders, analyzes protocols and related documents, and provides status updates to customers and leadership. The role collaborates with clinical trial nurses, pharmacists, clinical service areas, research teams, and other departments at Fred Hutch and UW. It also supports process improvement, training materials, onboarding, portfolio reporting, and effective use of project-management and other operational systems.

Requirements

Bachelor’s degree in science, technology, or a related field.
Five years of health care operations experience, preferably in clinical research.
Demonstrated ability to deliver outcomes in fast-paced environments.
Demonstrated ability to work effectively as a member of an interdisciplinary team.
Skills in critical thinking and problem solving.
Ability to process complex documents and extract key information.
Strong written and verbal communication skills.
Excellent attention to detail.
Customer-service orientation.

Nice To Haves

Five years of clinical research experience.
Project-management experience.
Experience with Zendesk or other customer-service software.
Certified Clinical Research Coordinator (ACRP), Certified Clinical Research Professional (SOCRA), or equivalent certification.
Oncology research experience.
Experience with a Clinical Trials Management System such as OnCore or Velos.

Responsibilities

Lead special projects and process-improvement efforts for the Clinical Readiness Team.
Guide Operations Specialists in managing higher-complexity issues escalated to the Director, at the Clinical Readiness Director’s request.
Track incoming implementation requests, manage their lifecycle, and escalate requests to the CRS Director as needed.
Identify opportunities to improve Clinical Readiness processes and documentation.
Develop, review, and revise training materials, SOPs, and work instructions; assist with onboarding new staff and refresher training.
Support portfolio management, including tracking and reporting portfolio health by disease group.
Track and manage a portfolio of 20 or more high-complexity clinical trials.
Set goals and timetables for each study and ensure clinic implementation activities for study startup are completed.
Maintain and track detailed project plans and issue trackers from pre-submission support through opening to accrual, and manage implementation of amendments through the study lifecycle.
Anticipate implementation issues and barriers and lead proactive efforts to resolve them.
Lead multidisciplinary project teams and collaborate with staff across Clinical Research Support and other Fred Hutch and UW departments.
Maintain clear, concise project-management documentation and provide effective written and oral communication, including exceptional note-taking.
Serve as the study liaison to other Center departments from a clinic implementation perspective and give presentations as needed.
Analyze complex clinical trial protocols and related documents, extract key information, and determine how research activities will integrate into clinic operations.
Identify operational workflow or training needs, implementation barriers, document inconsistencies, and areas requiring clarification; influence solutions and define pathways to resolution.
Apply expertise in Fred Hutch and UW operational practices to identify protocols that may not align with standard operating practices and require additional process analysis.
Lead stakeholder meetings by preparing agendas and pre-read materials, collecting and synthesizing input, guiding solution-oriented discussions, documenting minutes, and following up on action items.
Provide timely and accurate status updates to customers and leadership.
Organize and manage time and tasks independently.
Continually advocate for, identify, and lead process-improvement efforts.
Use and help improve project-management tools, ticketing systems, and Microsoft Office 365 tools to make processes more efficient and accurate.
Develop and/or present metrics, status updates, and escalations to senior leaders and other groups.

Benefits

Comprehensive benefits package designed to support health, well-being, and financial security.
Medical and vision benefits.
Dental insurance.
Flexible spending accounts.
Life insurance.
Disability benefits.
Retirement benefits.
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.