Clinical Data Standards Lead – Medidata Rave & SDTM

IQVIA; Miami (FL); On-site; USD 85,000 - 212,000; Full time

Job summary

IQVIA is seeking a Clinical Data Standards SME to design and optimize data models and metadata for global clinical studies in a fast-paced environment in Miami, FL. The role focuses on SDTM implementation, library development, and governance across study teams.

You will drive data standardization, collaborate with CROs, and mentor junior staff while ensuring adherence to CDISC guidelines and regulatory requirements.

Qualifications

• Medidata RAVE experience required.
• Medidata RAVE Custom Functions experience required.
• C# programming experience required.
• Standards governance experience (CDISC) required.

Responsibilities

• Participate in global clinical data standards development and maintenance, including SDTM mappings.
• Build and maintain the Medidata Rave global library standard objects to support study databases.
• Lead or participate in standards governance committees and cross-functional SOPs.

Skills

Medidata RAVE

Medidata RAVE Custom Functions

C# programming

CDISC Standards Governance

Education

MS/MA in life sciences or related

BS/BA in life science or related

High School degree

Tools

Medidata Rave

Rave Custom Functions

SDTM

Job description

IQVIA is seeking a Clinical Data Standards SME to design and optimize data models and metadata for global clinical studies in a fast-paced environment in Miami, FL. The role focuses on SDTM implementation, library development, and governance across study teams.

You will drive data standardization, collaborate with CROs, and mentor junior staff while ensuring adherence to CDISC guidelines and regulatory requirements.