Clinical Data Standards Manager - Medidata RAVE & SDTM

IQVIA

Newark (NJ)

On-site

USD 85,000 - 212,000

Full time

12 days ago

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Job summary

IQVIA is seeking a Clinical Data Standards SME to design and maintain global data standards and SDTM mappings for complex trials. You will contribute to global library objects, CRF design, guidance documents, and governance activities across CDMs and external partners.

Candidates must have Medidata RAVE experience, CDISC standards governance, and strong C# programming skills; advanced degree preferred; 4+ years of clinical data standards experience. IQVIA offers equal opportunity employment.

Qualifications

Medidata RAVE experience REQUIRED.
Medidata RAVE Custom Functions experience REQUIRED.
C# programming experience REQUIRED.
Standards Governance experience (CDISC) REQUIRED.
Candidates whose resumes do not clearly demonstrate these requirements will not be progressed for review.

Responsibilities

Develop and maintain global clinical data standards and SDTM mappings.
Build and maintain Medidata Rave global library objects and CRF completion guidelines.
Lead or participate in governance committees and cross-functional training.
Collaborate with study teams and external partners to ensure standards compliance and data quality.