Clinical Data Management Specialist

Job description

Clinical Data Management Specialist (bioMerieux, Inc., Salt Lake City, UT) Work independently and closely with both internal and external clinical trials partners such as Clinical Scientists (CS), Biostatisticians, Internal labs and clinical sites personnel. Review the Clinical Trial (CT) or associated studies documents from data capture, retrieval and handling perspectives. Understand data management needs and work closely with the CS to define the user requirements specifications. Build and maintain clinical databases (including specific programs) as per the pre-defined specifications. Use existing or set-up ad hoc new tools and processes for retrieving data. Follow appropriate verification and validation procedures to make the final database and retrieval tools ready to use. Define the monitoring requirements in collaboration with the CS and Biostatisticians if necessary. Review the monitoring strategy and develop or execute existing programs and set-up appropriate ad hoc tools as needed for the purpose of customized monitoring reports or equivalent, or basic statistical analysis. Collect, handle, and review data and manage queries along the CT or associated studies, as per resp...