Here at Seattle Children's we are united by a compelling mission: We provide hope, care and cures to help every child to live the healthiest and most fulfilling life possible. The Seattle Children’s Immunotherapy Integration Hub is seeking a Clinical Trial Manager to help us achieve this incredible mission.
As a Clinical Trial Manager you will manage the planning, implementation and completion of single and multi-site clinical trials for Seattle Children’s Immunotherapy Integration Hub. You will ensure research projects are conducted in compliance with applicable federal and local regulations, ICH/GCP, organization policies, and institutional/ departmental guidelines. The CTM will manage and monitor clinical sites, resources, and vendor(s) as applicable. Development and maintain study documents including protocols, plans, manuals, subject materials and forms. Train and mentor junior staff. Ensure trials meet determined timelines for key milestones and deliverables. Identify and implement process improvement ideas in collaboration with department staff. Assist with development of department infrastructure as required. The ideal candidate will have a patience, a great sense of humor and remain calm under pressure!
- Bachelor’s Degree in biological sciences or health-related field.
- Minimum of five (5) years’ experience as a clinical research associate or equivalent position, including at least two (2) years managing clinical studies for a sponsor organization, or equivalent application of research methodology in a clinical research setting.
- Experience leading teams in a matrixed environment.
- Experience in Phase 1 & 2 clinical research.
- Experience developing study materials (eg, protocols, plans, manuals).
- Experience evaluating site performance against established criteria.
- Seven (7) years of related experience in an FDA-GCP regulated industry.
- Clinical Research Associate certification.
- Masters Degree in biological sciences or health-related field.
- Experience managing complex oncology clinical trials.
- Experience managing vendor(s), eg,Contract Research Organization (CRO).
- Experience managing pediatric clinical trials.
- Experience working in an academic setting.
- Experience working with Lean or Six Sigma principles.