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.