Overview

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.

Key Responsibilities

• 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 AbbVie 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)
• Trial Design & Traceability
• 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 AbbVie standards and best practices
• Cross-Functional Collaboration
• Represent the Clinical Data Reporting & Standards group across cross-functional initiatives
• Ensure industry and AbbVie 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

Qualifications

• MS with 8+ years of relevant clinical research experience

Why Join Us?

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.