This role involves developing and designing clinical evaluation and component studies, ensuring scientific validity and alignment with program objectives. The position provides strategic input and hands-on development support for clinical plans and individual study protocols. Responsibilities include developing statistical analysis plans, performing data analysis of clinical trials, and participating in the development and maintenance of clinical operating guides. The role also supports secure, audit-ready study file management, assists in evaluating and integrating equipment, reagents, and quality control materials for clinical chemistry workflows, and reviews findings with management before implementation. Additionally, the position supports regulatory submissions by contributing clinical data analysis and study summaries.