Clinical Trial Manager, Immunotherapy

Here is a unique opportunity - Seattle Children's is building a Therapeutics core to support our mission to provide novel treatments to children. Our vision is to implement a pediatric nonprofit biotech business model to carry this treatment from bench to bedsite efficiently and effectively. The Trial Manager will coordinate the planning, implementation, and completion of single and multi-site clinical trials, ensuring research projects are conducted in compliance with applicable federal and local regulations, ICH/GCP, organization policies, and institutional/ departmental guidelines. Manage and monitor clinical sites, resources, and vendor(s) as applicable. Develop and maintain study documents including protocols, plans, manuals, subject materials and forms, and assist with development of department infrastructure as required. We are a team of strong people who care deeply about the work we do and try to have fun doing it!

Seattle Children's Employer Highlights:- Leader in Pediatric Care: Because of our people, Seattle Children's is recognized as a leading teaching, research and specialty care center at the forefront of pediatric care. - Competitive Benefits: We support a healthy work-life balance. Our benefits include employee care, paid time off, health insurance and retirement savings. - Transportation Discounts: Company bike program, on-site zip cars, unlimited ORCA transit pass, daily commute bonus provided to staff who us alternate methods of travel to/from work, company vanpools.- Diversity/Inclusion: We strive to maintain an atmosphere that reflects our values of inclusion by providing effective and respectful care compatible with each patient and family's beliefs, values, and heritage.

Required Education/Experience: - 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. Preferred: - 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.

Our community welcomes diverse experiences, backgrounds, and thoughts as this is what drives our spirit of inquiry and allows us to better connect with our increasingly diverse patients and families. Our organization recruits, employs, trains, compensates, and promotes without regard to race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.

The people who work at Seattle Children's are members of a community that seeks to respect and celebrate all the qualities that make each of us unique. Each of us is empowered to be ourselves within this community, which cultivates and promotes equity, diversity, and inclusion at all levels.

Seattle Children's is proud to be an Equal Opportunity Workplace and Affirmative Action Employer.