Clinical Trial Startup Project Manager

Fred Hutch Cancer Center; Seattle (WA); On-site; USD 90,000 - 140,000; Full time

Job summary

Fred Hutchinson Cancer Center seeks an experienced Clinical Trial Implementation Project Manager to drive clinic readiness for oncology and non-oncology trials, coordinating with Clinical Readiness and UW teams.

You will manage a portfolio of 20+ high-complexity trials, guide staff, and improve processes, ensuring study startup milestones are met and amendments are handled through lifecycle.

Responsibilities

• Lead special projects & process improvement efforts for the Clinical Readiness Team that manages clinic implementation for all Oncology trials implemented at UW & Fred Hutch as well as non-oncology trials at Fred Hutch.
• At the request of the Clinical Readiness Director, guide Operations Specialists in management of higher complexity issues that are escalated to the Director.
• Track incoming implementation requests, manage request lifecycle, and escalated requests to CRS Director as needed.
• Use independent judgement in interpreting and applying existing instructions and guidelines.
• Identify potential areas for improvement in Clinical Readiness processes and documentation.
• Develop, review and revise training materials, SOPs, Work Instructions and assist in onboarding new staff & supporting refresher training efforts.
• Support portfolio management activities such as trac…
• Track & manage a portfolio of 20+ high complexity clinical trials.
• Set goals and timetables for each study submitted to the Clinic Readiness team, ensuring that all clinic implementation activities related to study startup are completed.
• Using standard tools & templates, maintain and track detailed project plan & issues tracker for clinic implementation activities from pre-submission support to open to accrual; Subsequently support clinic implementation project management of amendments through the lifecycle of a study.
• Anticipate issues & barriers to study implementation and lead proactive steps to resolve issues & barriers.
• Lead multi-disciplinary project teams interacting with many different levels of staff within Clinical Research Support & other departments at Fred Hutch & UW.
• Effectively use written and oral communication skills. This includes exceptional note taking, maintaining clear, concise project management documents.
• Serve as study liaison, representing the study to other Center departments from a clinic implementation perspective. Give presentations as necessary.
• Analyze and apply expertise related multiple complex clinical trial protocols & associated documents.
• Draw out key information to help identify how research will be integrated into clinic activities.
• Call out areas and influence solutions where additional operational workflow/training are needed to accommod

Job description

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.

We are actively expanding our central research teams to support Principal Investigators (PIs) and study teams who are focused on mission-critical clinical trials programs. The Clinical Trial Implementation Project Manager will be primarily responsible for project managing clinic implementation activities to help ensure all clinical trial implementation gaps and issues for a study are identified and addressed in a timely manner until the trial is open to enrollment, and then subsequently project manage clinical trial implementation of amendments through the life cycle of the study. The role will also support portfolio management of 100+ active clinical trial submissions, training and process improvement. The role is a key member of the Clinical Readiness Team within the Fred Hutch Clinical Research Support Department, and actively collaborates with Clinical Trial Nurses, pharmacists, clinical service areas and research teams in driving implementation activities. This is a high-growth opportunity that allows for learning & impact in a variety of dimensions including cutting edge clinical trial operations, process improvement, technology tools and data-driven decision making.

Responsibilities

Portfolio Management & Process Improvement

• Lead special projects & process improvement efforts for the Clinical Readiness Team that manages clinic implementation for all Oncology trials implemented at UW & Fred Hutch as well as non-oncology trials at Fred Hutch.


• At the request of the Clinical Readiness Director, guide Operations Specialists in management of higher complexity issues that are escalated to the Director.


• Track incoming implementation requests, manage request lifecycle, and escalated requests to CRS Director as needed.


• Use independent judgement in interpreting and and applying existing instructions and guidelines.


• Identify potential areas for improvement in Clinical Readiness processes and documentation.


• Develop, review and revise training materials, SOPs, Work Instructions and assist in onboarding new staff & supporting refresher training efforts.


• Support portfolio management activities such as trac…

Clinical Trial Implementation Project Management

• Track & manage a portfolio of 20+ high complexity clinical trials.


• Set goals and timetables for each study submitted to the Clinic Readiness team, ensuring that all clinic implementation activities related to study startup are completed.


• Using standard tools & templates, maintain and track detailed project plan & issues tracker for clinic implementation activities from pre-submission support to open to accrual; Subsequently support clinic implementation project management of amendments through the lifecycle of a study.


• Anticipate issues & barriers to study implementation and lead proactive steps to resolve issues & barriers.


• Lead multi-disciplinary project teams interacting with many different levels of staff within Clinical Research Support & other departments at Fred Hutch & UW.


• Effectively use written and oral communication skills. This includes exceptional note taking, maintaining clear, concise project management documents.


• Serve as study liaison, representing the study to other Center departments from a clinic implementation perspective. Give presentations as necessary.


• Analyze and apply expertise related multiple complex clinical trial protocols & associated documents.


• Draw out key information to help identify how research will be integrated into clinic activities.


• Call out areas and influence solutions where additional operational workflow/training are needed to accommod