Senior Clinical Studies Scientist - (Chaska, MN)

Reporting to the Sr. Manager of Clinical Affairs for Chemistry & Immunoassay businesses at Beckman Coulter, the Senior Clinical Study Scientist is responsible for the execution of external clinical study deliverables following GCP, FDA and OUS qualifications. You should be experienced in the field of in vitro diagnostics with good understanding of disease states and understands the laboratory environment as well as the basic product development process. Works under the general guidance of Staff Clinical Scientist or assigned Clinical Study lead for the project to prepare deliverables for the external validation activities for 1 or more assigned projects. Participates in the key phases of the external clinical study, including: planning, execution, analysis & close-out. This includes drafting the many necessary documents for each phase. Planning phase activities may include literature search and product evidence strategy plan development, as well as study site qualification visits and reports.