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)
- 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
- 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
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.
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