Clinical Trial Startup Implementation Lead

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

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.