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. 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. #J-18808-Ljbffr K3-Innovations, Inc.