Clinical Data Standards Manager III

We are seeking a highly experienced Data Standards Manager III to join our Clinical Data Reporting & Standards team. This role plays a critical leadership function in ensuring clinical data standards are consistently applied across studies, from data collection through regulatory submission. The ideal candidate is a subject matter expert in CDISC standards with strong communication skills and the ability to influence cross-functional teams.

• eCRF Design
  • Critically review eCRF designs to ensure alignment with CDASH and SDTM standards
  • Identify limitations in eCRF design and proactively collaborate with study teams to resolve issues
• SDTM Conformance & Mapping
  • Create and review SDTM conformance mapping specifications using SDTM, TAUG, and Abb Vie standards
  • Support complex, study-specific data mapping to SDTM
• CDISC Validation
  • Execute CDISC validation tools (e.g., Pinnacle 21)
  • Partner with cross-functional teams to resolve validation issues and ensure appropriate documentation of unresolved findings (e.g., Clinical Study Data Reviewer’s Guides)
  • Create and review Trial Design domains
  • Maintain a clear understanding of end-to-end traceability from data collection through reporting
• Metadata Repository & Governance
  • Manage CDISC-related metadata, terminology, and standards within the metadata repository
  • Provide governance oversight to Data Standards Analysts and Senior Data Standards Analysts to ensure metadata consistency
• Standards Development & Governance
  • Assist in the development and evolution of data standards
  • Guide study teams on the appropriate use of Abb Vie standards and best practices
• Cross-Functional Collaboration
  • Represent the Clinical Data Reporting & Standards group across cross-functional initiatives
  • Ensure industry and Abb Vie standards are understood and followed
• Communication & Influence
  • Clearly articulate clinical data standards concepts, regulatory guidance, and clinical principles
  • Effectively present logical, persuasive arguments to programmers, statisticians, data scientists, clinical development, and regulatory stakeholders
  • Diplomatically advocate for Data Standards priorities in cross-functional settings

• MS with 8+ years of relevant clinical research experience
• OR BS with 12+ years of relevant experience
• Expert‑level knowledge of CDASH, SDTM, define.xml, and CDISC controlled terminology
• Proven experience mapping and converting legacy data into SDTM domains for eCTD submissions
• Minimum of two successful regulatory submissions with CDISC‑compliant data
• Strong understanding of international regulations and regulatory guidance related to clinical data standards
• Hands‑on experience with metadata repository technologies and data standards governance

This is an opportunity to make a meaningful impact on global clinical data standards while working remotely with a collaborative, highly skilled team. You’ll operate at a strategic level, influencing how clinical data is structured, governed, and delivered for regulatory success.