Description

Position Summary:

Responsible for conceptualizing, organizing, and overseeing data management activities for the Clinical Affairs department. Manage Clinical Data Specialists to ensure all aspects of study data collection, management, and analysis meet the requirements to support regulatory submission of bioMrieux's molecular in vitro diagnostic products or other research activities. Make significant contributions to the generation of documents (e.g., study reports) that support regulatory submissions.

Primary Duties:

• Perform all work in compliance with company policy and within the guidelines of bioMrieuxs Quality System.
• Conceptualize and execute clinical and analytical study design with respect to data collection, management, and analysis.
• Manage Clinical Data Specialists in the design and execution of study-specific data management activities from study start-up through database lock and regulatory submission, including when necessary:
• Case Report Form (CRF) design,
• development of electronic data capture (EDC) database specifications,
• formulation and validation of 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.
• Oversee Clinical Data Specialists to ensure that clinical and analytical data is reviewed and verified for integrity, adequacy, and accuracy and the resolution of queries with clinical sites.
• Create specifications and work with internal software teams to design highly efficient tools to organize and report on clinical and analytical study data from multiple sources (hard-copy CRFs, EDC systems, SLC BIOFIRE run database, Microsoft Excel spreadsheets, etc.).
• Identify requirements for study metrics and ensure that the Clinical Data Specialists perform ongoing data analyses and tracking of data anomalies.
• Oversee the development of processes to automate and validate data retrieval, manipulation, and analysis, including performing statistical calculations and creating visualization tools.
• Significantly participate in writing study reports that will be used to support regulatory submissions.
• Represent Clinical Affairs for collaboration with Software teams in review of pouch module specifications, V&Vs, technical reviews, melt range analyses, and other software documents.
• Maintain current Human Subjects Protections training through an accredited program (e.g., CITI).

• This position requires excellent written and oral communication skills.
• The ability to work closely with Associate Director, Clinical Data Management to identify and communicate areas of technical, schedule, and budget risk.
• Excellent organizational skills are essential.
• Manages/supervises 1-3 Clinical Data Specialists.
• May work remotely.

Training and Education:

• Bachelor's degree in a scientific discipline.
• Master's degree or specialized training in Clinical Data Management is preferred.

Experience:

• At least 6 years of experience in managing large clinical data sets.
• Experience with working on clinical evaluations within the medical device and/or pharmaceutical industry.

Knowledge, Skills, and Abilities:

• Advanced level user of Microsoft Excel.
• Working knowledge of database applications, such as Microsoft Access (including Structured Query Language; SQL) and EDC systems.
• Basic statistical techniques.
• Writing and presentation skills.