Clinical Trial Startup Project Manager

Fred Hutchinson Cancer Center (Fred Hutch); Seattle (WA); On-site; USD 82,000 - 124,000; Full time

Benefits offered by this job

Medical/vision

Dental

Flexible spending accounts

Life

Disability

Retirement

Family life support

Employee assistance program

Onsite health clinic

Tuition reimbursement

Paid vacation

Paid sick leave

Paid holidays

Paid parental leave

Job summary

Fred Hutchinson Cancer Center in Seattle is seeking a Clinical Trial Startup Project Manager to lead clinic implementation for oncology and non-oncology trials, manage a large portfolio, and drive process improvements. You will work with Clinical Readiness teams, trial nurses, pharmacists, and other departments to ensure studies move from pre-submission to open accrual and through amendments.

The role requires a Bachelor’s degree in science/related field, 5 years of healthcare/clinical research

Qualifications

• Bachelor's degree in science, technology, or related field.
• 5 years of health care operations experience preferably in clinical research.
• 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.
• Strong written and verbal communication skills
• Excellent attention to detail
• Customer service oriented

Responsibilities

• Lead portfolio management and process improvement efforts for the Clinical Readiness Team.
• Guide Operations Specialists in high-complexity issue management.
• Track implementation requests and manage lifecycles.
• Develop and revise training materials, SOPs and onboarding materials.
• Support portfolio health tracking and reporting.
• Track and manage a portfolio of 20+ high complexity clinical trials.
• Lead multi-disciplinary project teams and maintain clear project management documentation.
• Coordinate stakeholder meetings and communicate status to leadership.

Skills

Communication skills

Team collaboration

Critical thinking

Attention to detail

Customer service

Problem solving

Education

Bachelor's degree in science/related field

Tools

Zendesk

OnCore

Velos

Smartsheet

Office 365

Job description

Clinical Trial Startup Project Manager

Job ID 32027

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.

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 elevate 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 tracking & reporting on overall health of portfolio by disease group.

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 accommodate protocol activities and identify implementation barriers.
  • Troubleshoot any areas where documents are inconsistent or require additional clarification and define pathways to resolution.
• Serve as subject matter expert on operational practices at Fred Hutch and UW to help identify where specific protocols may not adhere to standard operating practices and require additional process analysis before they can be implemented.
• Lead stakeholder meetings, prepping agendas and pre-read materials, collecting & synthesizing inputs, guiding discussions in a solution-oriented way, documenting minutes, and following up on action items.
• Provide timely & accurate updates on status to customers and leadership.
• Organize and manage time and tasks independently.
• Continually advocate, identify & lead process improvement efforts
• Work with a variety of systems and tools including project management tools such as Smartsheet, ticketing systems such as Zendesk, Microsoft Office 365 tools - actively work to enhance how systems can be used to make processes more efficient & accurate.
• Develop and/or present metrics, status updates and escalations to senior leaders and other groups.

Qualifications

Required

• Bachelor's degree in science, technology, or related field
• 5 years of health care operations experience preferably in clinical research.
• 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.
• Strong written and verbal communication skills
• Excellent attention to detail
• Customer service oriented

Preferred

• 5 years of clinical research experience
• Project Management experience
• Experience with Zendesk or other customer service software
• Certified Clinical Research Coordinator (ACRP), Certified Clinical Research Professional (SOCRA), or equivalent certification preferred.
• Oncology research experience
• Experience with Clinical Trials Management System (i.e., OnCore, Velos, etc.)

The annual base salary range for this position is from $82,493.00 to $123,697.00, 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.

• 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)
• 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.