Clinical Data Standards Specialist

2 days ago


Dublin, Dublin City, Ireland beBeeStandards Full time €98,352 - €124,576
Clinical Data Standards Specialist

Our team seeks an experienced Clinical Data Standards Specialist to streamline clinical data processes across various therapeutic areas, ensuring high-quality data collection and delivery.

Key Responsibilities:
  • Implement standard content in data collection and delivery tools, driving consistency, automation, and efficiency across clinical trials.
  • Configure standards for specific therapeutic or disease areas to enable optimal reuse and adoption across the research and development portfolio.
  • Collaborate with cross-functional teams to ensure correct configuration and adoption of clinical data standards.
  • Maintain compliance with industry standards (e.g., CDISC) and health authority regulations.
  • Conduct testing and quality control of tools, mapping metadata, and standard implementations.
Requirements:
  • Bachelor's degree in life sciences, computer science, or equivalent experience.
  • Minimum of 2 years' relevant operational experience in clinical data management or data standards.
  • Strong expertise in Rave eDC (Medidata Solutions).
  • Experience with SAS programming; coding skills preferred.
  • In-depth understanding of CDISC standards: SDTM, CDASH, define.xml, and controlled terminology.

We are seeking a professional who can drive innovation and improvement in our clinical data processes. The ideal candidate will have excellent communication skills, be able to work effectively in a team environment, and possess a strong attention to detail.



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