Clinical Data Manager

AurigaVision AG seeks a Clinical Data Manager in Basel for a hybrid, mid-level role. The position focuses on EDC database design, CDISC compliance, and leading database lock activities.

This position is responsible for the end-to-end management of clinical data, including the design and construction of databases within Electronic Data Capture (EDC) platforms. The role ensures that all data activities adhere to CDISC standards and prepares datasets for statistical analysis by coordinating database lock procedures with biostatistics teams.

Responsibilities

• Construct and configure clinical databases using EDC software.
• Create data validation checks, edit rules, and review listings to ensure data quality.
• Execute data cleaning processes, manage queries, and review medical coding.
• Maintain CDISC compliance throughout all clinical data operations.
• Oversee database lock procedures and work closely with biostatistics to ensure analysis readiness.

Requirements

• Bachelor's or Master's degree in Life Sciences, Computer Science, or a related discipline.
• Three to five years of experience in clinical data management within pharmaceutical or CRO environments.
• Demonstrated proficiency with at least one primary EDC system.
• Solid understanding of CDISC standards and FDA/EMA data submission guidelines.
• Exceptional attention to detail and the ability to handle multiple studies simultaneously.

Nice to have

• Experience with Medidata Rave.