Clinical Data Standards Consultant

Job Summary

To support operational staff in utilizing ADaM and define.xml for statistical analysis, the full-time remote Clinical Data Standards Consultant will develop tools for efficient data collection and reporting, mentor team members, and consult with clients on CDISC implementation projects.

Key responsibilities

• Serve on Sponsor Standards and Technology Leadership teams and consult on sponsor-specific CDISC implementation projects
• Author and maintain Standards Related Project Plans while implementing strategies for managing CDISC metadata repositories
• Identify process improvement opportunities to enhance productivity, quality, and compliance in data collection and reporting

Required qualifications

• Minimum of 5 years of experience in a role demonstrating knowledge of biometrics standards
• An undergraduate degree or international equivalent from an accredited institution
• Demonstrated expertise in CDASH and SDTM standards with a strong understanding of CRF design concepts
• Excellent communication skills with proven leadership abilities