Sr. Clinical Trial Startup Project Manager

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.

• 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.

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 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 $95,493 to $143,208, 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).