Expert Clinical Data Standards Specialist

7 days ago

Dublin, Dublin City, Ireland beBeeClinicalDataStandards Full time €60,000 - €99,999
Master Clinical Data Standards Expert

Maximize the value of clinical data by ensuring its quality and integrity.

Key Responsibilities:

  • Develop and implement standards for data collection and delivery to enhance consistency, automation, and efficiency in clinical trials.
  • Configure standards for specific therapeutic or disease areas to enable optimal reuse and adoption across the R&D portfolio.
  • Collaborate with cross-functional teams to ensure correct configuration and adoption of clinical data standards.
  • Maintain and govern master-level data collection and delivery standards, applying formal change control and versioning practices.
  • Ensure compliance with industry standards (e.g., CDISC) and health authority regulations, incorporating best practices in computer system validation.
  • Support lineage and traceability documentation for all pre-configured standards used across studies.
  • Provide subject matter expertise to internal teams and external partners on the adoption and implementation of clinical data standards.
  • Develop and maintain standard CRF mockups, questionnaires, validation rule specifications, and integrations (e.g., IWRS).

Requirements:

  • Bachelor's degree in Life Sciences, Computer Sciences, 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.
  • Familiarity with SAS LSAF and Pinnacle 21 is advantageous.
  • Ability to manage multiple priorities effectively in a matrixed environment.

Desirable Skills:

  • Excellent communication skills, both written and verbal, in English.
  • Strong collaboration mindset with the ability to work across global teams and stakeholders.
  • High attention to detail and a structured, analytical approach to problem-solving.

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