Senior Oncology Trial Startup Lead

Fred Hutchinson Cancer Center (Fred Hutch); Seattle (WA); On-site; USD 95,000 - 143,000; Full time

Job summary

Fred Hutchinson Cancer Center in Seattle, WA is seeking a Sr. Clinical Trial Startup Project Manager to lead startup activities for a portfolio of complex oncology studies from feasibility to activation.

You will drive standardized start-up practices and coordinate with investigators, sponsors, regulatory teams, and clinic units to ensure compliant readiness for enrollment. This role requires at least five years post-master s or seven years post-bachelors of related project management in

Qualifications

• Minimum of five years post-masters or seven years post-bachelors related project/study management experience in a research setting
• Excellent written and verbal communication skills.
• Ability to relate to and coordinate with multidisciplinary and culturally diverse research, technical and management staff.
• 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.

Responsibilities

• Independently manage an assigned portfolio of complex oncology clinical research studies from feasibility through activation.
• Carry significant portfolio volumes of about 30+ submissions
• Lead study kick-off meetings and develop study-specific start-up work plans, issue trackers and activation-readiness checklists.
• Coordinate and track critical start-up workstreams, including:
• Initial study intake, triage, and feasibility assessment.
• Protocol operational review and implementation planning.
• Sponsor, CRO, investigator, and institutional stakeholder communications.
• Coordination with finance, contracts, regulatory and clinic implementation nurses.
• Identify potential delays early, develop mitigation plans, elevate unresolved barriers through established governance structures, and drive stakeholders toward timely decisions.
• Facilitate cross-functional study meetings, document decisions and action items, and ensure timely follow-up.
• Provide investigators, study teams, sponsors, and leadership with clear, concise, and timely status updates.
• Support handoff from start-up to ongoing study conduct, including transfer of key operational documents, workflow decisions, and unresolved post-activation tasks.
• Personally assume or co-manage projects when a study requires senior project-management expertise, intensive stakeholder intervention, accelerated activation, remediation, or continuity support.
• Escalate organizational barriers and resource risks to leadership or appropriate governance body with a concise description of impact, options, recommendation, and required decision.
• Develop, maintain, and improve standardized tools and processes for start-up project management
• Use project-level insight and portfolio data to recommend process improvements, workflow redesign, technology enhancements, and policy changes.
• Support development, implementation, and revision of SOPs, work instructions, templates, training materials, and governance standards related to study activation.

Skills

Excellent written and verbal comms

Coordination with multidisciplinary &

Fast-paced delivery

Interdisciplinary teamwork

Forecasting & deadlines

CTMS familiarity

Excel proficiency

MS Word proficiency

Acrobat proficiency

Tools

CTMS

Epic

Excel

MS Word

Acrobat

Job description

Fred Hutchinson Cancer Center in Seattle, WA is seeking a Sr. Clinical Trial Startup Project Manager to lead startup activities for a portfolio of complex oncology studies from feasibility to activation.

You will drive standardized start-up practices and coordinate with investigators, sponsors, regulatory teams, and clinic units to ensure compliant readiness for enrollment. This role requires at least five years post-master s or seven years post-bachelors of related project management in