Sr. Clinical Trial Startup Project Manager

Fred Hutchinson Cancer Center•Seattle, WA

About The Position

The Sr. Clinical Trial Startup Project Manager directly manages a portfolio of complex clinical research studies from intake through activation and drives start-up process improvement. The role independently leads start-up activities for selected high-priority, novel, operationally complex, investigator-initiated, multi-site, high-revenue, accelerated-timeline, or otherwise high-risk trials. It also establishes standardized start-up practices, improves processes, and removes barriers. The position partners closely with principal investigators, study teams, sponsors, regulatory teams, research finance, contracting, clinic service areas, and other institutional stakeholders to support efficient, compliant study activation and operational readiness for enrollment. The manager may carry a significant portfolio volume of approximately 30 or more submissions and may assume or co-manage projects requiring senior project-management expertise, intensive stakeholder intervention, accelerated activation, remediation, or continuity support. Fred Hutchinson Cancer Center is an independent nonprofit organization focused on adult cancer treatment and research in cancer and infectious diseases. Based in Seattle, it is Washington’s only National Cancer Institute-designated cancer center and operates eight clinical care sites, with hospital network affiliations in five states. Its mission is to discover cures for serious diseases and make life beyond cancer a reality. The organization values collaboration, compassion, determination, excellence, innovation, integrity, and respect.

Requirements

Minimum of five years of related project or study management experience in a research setting after a master’s degree, or seven years after a bachelor’s degree.
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 effectively as a member of an interdisciplinary team.
Critical-thinking and problem-solving skills.
Ability to process complex documents and extract key information.
Experience working with multidisciplinary teams.
Ability to forecast and meet deadlines.
Familiarity with project-management tools and techniques.
Familiarity with clinical trial management systems (CTMS) and systems supporting workflow and metrics.
Proficiency with Excel, Microsoft Word, and Acrobat.
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, professional working relationships with internal and external stakeholders.

Nice To Haves

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

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 strategically significant studies.
Carry significant portfolio volumes of approximately 30 or more submissions.
Lead study kick-off meetings and develop study-specific start-up work plans, issue trackers, and activation-readiness checklists.
Coordinate and track study intake, triage, feasibility assessment, protocol operational review, and implementation planning.
Coordinate communications among sponsors, CROs, investigators, and institutional stakeholders.
Coordinate start-up workstreams with finance, contracts, regulatory teams, and clinic implementation nurses.
Identify potential delays, develop mitigation plans, escalate unresolved barriers through governance structures, and drive timely stakeholder 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, timely status updates.
Support handoff from start-up to ongoing study conduct by transferring key operational documents and workflow decisions and identifying unresolved post-activation tasks.
Assume or co-manage projects requiring senior project-management expertise, intensive stakeholder intervention, accelerated activation, remediation, or continuity support.
Escalate organizational barriers and resource risks to leadership or an appropriate governance body, describing impacts, options, recommendations, and required decisions.
Develop, maintain, and improve standardized study start-up project-management tools and processes.
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.