Data Standards Manager

Job Summary

A company is looking for a Data Standards Manager to provide governance oversight and ensure consistency in metadata.

Key Responsibilities

• Provide governance oversight to Data Standards Analysts to ensure metadata consistency
• Review eCRF designs and create SDTM conformance mapping specifications
• Manage CDISC-related metadata and assist in the development of data standards

Required Qualifications

• MS with 8 years or BS with 12 years of relevant clinical research experience
• Expert knowledge of CDASH, SDTM, define.xml, and controlled terminology
• Experience in mapping legacy data into SDTM domains for eCTD submissions
• Minimum of two successful submissions of CDISC compliant data
• Experience with metadata repository technology and stakeholder management