Clinical Data Standards Manager III

K3-Innovations, Inc.; United States; Remote; USD 100,000 - 130,000; Full time

Job summary

A leading clinical data standards firm is seeking a highly experienced Data Standards Manager III to ensure clinical data standards are applied across studies. The ideal candidate will manage eCRF design, SDTM mapping, and validation processes, while guiding cross-functional teams on best practices. A strong background in CDISC standards and significant clinical research experience are required. This remote position offers the opportunity to impact global clinical data governance significantly.

Qualifications

• MS with 8+ years of relevant clinical research experience.
• Expert-level knowledge of CDASH, SDTM, and CDISC controlled terminology.
• Proven experience mapping legacy data into SDTM for eCTD submissions.

Responsibilities

• Critically review eCRF designs to ensure alignment with CDASH and SDTM standards.
• Create and review SDTM conformance mapping specifications.
• Execute CDISC validation tools and resolve validation issues.

Skills

CDISC standards expertise

Strong communication skills

Cross-functional collaboration

eCRF design knowledge

SDTM mapping experience

Education

MS with 8+ years of clinical research experience

BS with 12+ years of clinical research experience

Tools

Pinnacle 21

Metadata repository technologies

Job description

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.