Sr. Clinical Trial Startup Project Manager

Fred Hutchinson Cancer Center (Fred Hutch); Seattle (WA); Presencial; USD 95.000 - 143.000; Tempo integral

Resumo da vaga

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

Qualificações

• 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.

Responsabilidades

• 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.

Conhecimentos

Excellent written and verbal comms

Coordination with multidisciplinary &

Fast-paced delivery

Interdisciplinary teamwork

Forecasting & deadlines

CTMS familiarity

Excel proficiency

MS Word proficiency

Acrobat proficiency

Ferramentas

CTMS

Epic

Excel

MS Word

Acrobat

Descrição da vaga

Sr. Clinical Trial Startup Project Manager

Job ID: 32207

Type: Regular Full-Time

Location: US-WA-Seattle

Category: Clinical Research Support Services

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 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).

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 [e-mail] or by calling 206-667-4700.