The Clinical Data Specialist (CDS) 1 is responsible for assisting with aspects of study data management for the Clinical Affairs department. The CDS 1 will assist with all aspects of study data collection, management, and analysis required to support regulatory submission of bioMérieux’s in vitro diagnostic products or other research activities. The CDS 1 will also help coordinate activities and experiments related to investigating data/performance discrepancies that occur during the studies. Primary Duties: + Perform all work in compliance with company policy and within the guidelines of bioMérieux’s Quality System. + Execute clinical and analytical study design with respect to data collection, management, and analysis. + Assist with study-specific data management activities from study start-up through database lock and regulatory submission, including when necessary: + Case Report Form design, + development of electronic data capture (EDC) database specifications, + formulation and validation of and edit check specifications and query logic, + development and maintenance of project-specific Data Management Plans, and + preparation of data elements for clinical and analytical study reports and 510(k) submissions. + Create or follow specifications and design highly efficient tools to organize and report on clinical and analytical study data from multiple sources (hard-copy CRFs, EDC systems, instrument run databases, Microsoft Excel spreadsheets, etc.). + Follow requirements for study metrics and perform ongoing data analyses and tracking of data anomalies. + Review and perform verification of clinical and analytical study data for ALCOA+; generate and resolve queries with clinical sites. + Communicate up-to-date analyses of clinical and analytical study performance and progress throughout duration of studies. + Coordinate investigation of data/performance discrepancies. + Participate in preparation of data elements for clinical and analytical study reports. + Maintain current Human Subjects Protections training through an accredited program (e.g., CITI). + Selects appropriate ways to present clinical and analytical data. + Performs other duties as assigned. Minimum Qualification: + Bachelor's degree in a scientific discipline. + At least 2 years of experience in managing large data sets (clinical or other research data preferable). + Molecular biology and/or microbiology experience is preferred.