Clinical Data Standards Associate

Job Summary

Supporting the development and maintenance of global clinical data standards, the full-time remote Senior Associate, Clinical Data Standards Management (CDSM) will collaborate with cross-functional teams to ensure high-quality and regulatory-compliant standards implementation across clinical programs.

Key responsibilities

• Support the development and maintenance of global clinical data standards and operational data mappings
• Apply CDISC standards in standards development and assist in regular releases of the Global Library Volume
• Provide study support during the initial EDC build on new studies, ensuring compliance with regulatory requirements and industry standards

Required qualifications

• Doctorate, Master's with 3+ years, or Bachelor's with 5+ years of experience in Clinical Data Standards or EDC Programming
• Strong working knowledge of CDISC standards (CDASH, SDTM, ADaM)
• Experience programming in Medidata Rave EDC and familiarity with its modules
• Understanding of clinical trial data collection processes and CRF design
• Familiarity with FDA, EMA, ICH, and GCP requirements