Clinical Data Standards Lead (Medidata RAVE)

IQVIA; Durham (NC); On-site; USD 85,000 - 212,000; Full time

Job summary

IQVIA is seeking a Standards SME to design and maintain global clinical data standards, SDTM mappings, and global library objects. You will collaborate with Data Managers, EDC Programmers, and external partners to ensure compliant data collection.

The role requires Medidata RAVE expertise, C# programming, and governance experience. You will develop CRF guidelines, participate in standards committees, and mentor junior staff while aligning with regulatory guidelines.

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 Medidata RAVE, Custom Functions, C#, and Standards Governance experience will not be progressed for review.

Responsibilities

• Participate in developing Global Clinical Data Standards and other cross-functional SOPs, Working Procedures, Guidance documents, and job aids.
• Develop and maintain global library objects (eCRF forms, edit checks) and CRF Completion Guidelines.
• Support Standards Core Committee and Governance activities; prepare materials for approval processes.
• Communicate content and interpretation of Kite data standards across project teams for consistency.
• Liaise with external partners and review deliverables against standards requirements.

Skills

Medidata RAVE

Medidata RAVE Custom Functions

C# programming

CDISC Standards Governance

Education

Medidata MS/MA in life sciences or related discipline

BS/BA in life science or related discipline

High School degree + 10+ years experience in Clinical Data Standards

Tools

Medidata Rave

Veeva

Medrio

Oracle

Job description

IQVIA is seeking a Standards SME to design and maintain global clinical data standards, SDTM mappings, and global library objects. You will collaborate with Data Managers, EDC Programmers, and external partners to ensure compliant data collection.

The role requires Medidata RAVE expertise, C# programming, and governance experience. You will develop CRF guidelines, participate in standards committees, and mentor junior staff while aligning with regulatory guidelines.