What are the responsibilities and job description for the Clinical Data Specialist 1 position at bioMérieux?
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.
