Clinical Data Expert

2 weeks ago

Dublin, Dublin City, Ireland beBeeDataStandards Full time €75,000 - €90,000
Clinical Data Standards Architect

As a Clinical Data Standards Architect, you will play a pivotal role in ensuring the quality and integrity of clinical data. This position requires strong expertise in developing, implementing, and maintaining standard metadata across the entire data lifecycle.

Key Responsibilities:
  • Develop and implement standard metadata to support data collection, processing, and submission.
  • Implement standard content in data collection and delivery tools to drive consistency, automation, and efficiency.
  • Configure standards for specific therapeutic areas to enable optimal reuse and adoption.
  • Collaborate with cross-functional teams to ensure correct configuration and adoption of clinical data standards.
  • Ensure compliance with industry standards (e.g., CDISC) and health authority regulations.

Requirements:

  • Bachelor's degree in Life Sciences, Computer Sciences, or equivalent experience.
  • Minimum 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.

About this Role:

  • We value diversity and inclusion.
  • We offer a competitive salary and benefits package.
  • We prioritize work-life balance and well-being.

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