Sr. Clinical Trial Startup Project Manager

Fred Hutch Cancer Center; Seattle (WA); In loco; USD 120.000 - 160.000; Tempo pieno

Descrizione del lavoro

Fred Hutchinson Cancer Center in Seattle seeks a Sr. Clinical Trial Startup Project Manager to independently lead startup activities for complex oncology studies. You will partner with investigators, sponsors, regulatory teams, and clinics to ensure efficient activation and readiness for enrollment.

The role requires strong program management skills, the ability to navigate multi-site operations, and a track record of delivering projects on accelerated timelines in a research setting.

Competenze

• Five+ years of project/study management experience in a research setting.
• Excellent written and verbal communication skills.
• Ability to coordinate with multidisciplinary teams.
• Proven ability to deliver outcomes in fast-paced environments.
• Experience managing oncology studies and start-up activities.

Mansioni

• Independently manage a portfolio of complex oncology studies from feasibility through activation.
• Lead study kick-off meetings and develop start-up work plans.
• Coordinate and track start-up workstreams and activation-readiness checklists.
• Identify delays early and drive timely decisions with governance.
• Provide concise status updates to investigators, sponsors, and leadership.
• Support handoff from start-up to ongoing study conduct.

Conoscenze

Stakeholder management

Written and verbal communication

Cross-functional collaboration

Problem solving

Descrizione del lavoro

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 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, 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.

Qualifications

MINIMUM QUALIFICATIONS:

• Minimum of five years post-master's 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 docum