Clinical Data Specialist 1

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:

1. Perform all work in compliance with company policy and within the guidelines of bioMérieux’s Quality System.
2. Execute clinical and analytical study design with respect to data collection, management, and analysis.
3. Assist with study-specific data management activities from study start-up through database lock and regulatory submission, including when necessary:
1. Case Report Form design,
2. development of electronic data capture (EDC) database specifications,
3. formulation and validation of and edit check specifications and query logic,
4. development and maintenance of project-specific Data Management Plans, and
5. preparation of data elements for clinical and analytical study reports and 510(k) submissions.
4. 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.).
5. Follow requirements for study metrics and perform ongoing data analyses and tracking of data anomalies.
6. Review and perform verification of clinical and analytical study data for ALCOA+; generate and resolve queries with clinical sites.
7. Communicate up-to-date analyses of clinical and analytical study performance and progress throughout duration of studies.
8. Coordinate investigation of data/performance discrepancies.
9. Participate in preparation of data elements for clinical and analytical study reports.
10. Maintain current Human Subjects Protections training through an accredited program (e.g., CITI).
11. Selects appropriate ways to present clinical and analytical data.
12. 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.