Sr. Clinical Trial Startup Project 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 worlds 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 worlds 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 Sr. Clinical Trial Startup Project Manager is responsible for directly managing a portfolio of complex clinical research studies from intake through activation and driving startup process improvement. The role independently leads start-up activities for selected studies including high-priority novel operationally complex investigator-initiated multi-site high-revenue accelerated-timeline or otherwise high-risk trials. The role also establishes standardized start-up practices drives process improvement and removes barriers.

This role partners closely with principal investigators study teams sponsors regulatory teams research finance contracting clinic service areas and other institutional stakeholders to ensure studies are activated efficiently compliantly and with clear operational readiness for enrollment.

Responsibilities

• Independently manage an assigned portfolio of complex oncology clinical research studies from feasibility through activation including investigator-initiated sponsor-initiated multi-site investigational drug device cellular therapy high-acuity accelerated-timeline and other strategically significant studies.
• 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 escalate 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.

Qualifications

MINIMUM 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.

PREFERRED QUALIFICATIONS:

• Clinical research-related certification preferred.
• Experience with Clinical Trial Management Systems (CTMS) preferred.
• Experience working in Epic preferred.
• Experience with multi-site clinical research projects and NIH grants and contracts preferred.
• Excellent computer skills including ability to use wide variety of software packages for research data management.

The annual base salary range for this position is from $95493 to $143208 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 or by calling .

Required Experience:

Senior IC