Clinical Data Standards Lead — Medidata Rave & SDTM Expert

IQVIA; New York (NY); On-site; USD 85,000 - 212,000; Full time

Job summary

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence. We are seeking a Clinical Data Standards SME to design or modify data models that meet business and application needs and organize metadata for cross‑team use.

The role emphasizes SDTM/CDISC standards, global library development, governance participation, and collaboration with data managers, EDM programmers, and external partners to ensure compliant data collection and reporting

Qualifications

• Medidata RAVE and Custom Functions experience are mandatory.
• Strong knowledge of CDISC SDTM and data mapping.
• Experience with SDLC and technical writing.

Responsibilities

• Develop and maintain global clinical data standards and mappings using SDTM.
• Manage global library objects and ensure timely delivery.
• Support Standards Governance and committee activities.
• Document procedures and ensure compliance with industry guidelines.
• Collaborate with study teams and external partners.
• Provide mentoring and training on data standards processes.

Skills

Medidata RAVE

Medidata RAVE Custom Functions

C# programming

Standards Governance

Education

MS/MA in life sciences or related discipline

BS/BA in life sciences or related discipline

High School + 10+ years in Clinical Data Standards

Job description

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence. We are seeking a Clinical Data Standards SME to design or modify data models that meet business and application needs and organize metadata for cross‑team use.

The role emphasizes SDTM/CDISC standards, global library development, governance participation, and collaboration with data managers, EDM programmers, and external partners to ensure compliant data collection and reporting