Remote 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

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.