Clinical Data Standards Consultant

ICON plc

Clinical Data Standards Consultant supporting operational staff in ADaM and define.xml for statistical analysis. Leading standard-related project plans and mentoring consultants in a diverse clinical research environment.

Posted 6/25/2026full-timeFrankfurt • 🇩🇪 GermanyMid-LevelSeniorWebsite

About the role

Key responsibilities & impact

Serve on Sponsor Standards and Technology Leadership teams.
Consult with clients on sponsor-specific CDISC centric implementation projects.
Participate in industry groups focused on the development of standards related initiatives (e.g. CDISC, PhUSE etc.).
Author, maintain, implement, and report status for Standards Related Project Plans.
Responsible for the implementation, strategy, and configuration of a metadata repository used to manage libraries of CDISC related metadata, terminology and related standards.
Mentor Clinical Data Standards Consultants.
Lead Subject Matter Expert teams on topics relevant to standards.
Identify areas for process improvement which may increase productivity, quality and / or compliance of deliverables in the areas from data collections through analysis and reporting.
Participate in the analysis of metrics and in creating recommendations to the management teams on process improvements together with the Director of Global Data Standards.

Requirements

What you’ll need

Minimum of 5 years of experience in industry in a role demonstrating knowledge of clinical data standards used by biometrics.
An undergraduate degree or international equivalent from an accredited institution
Demonstrated expertise in CDASH, SDTM standards and associated controlled terminology with a good understanding of CRF design concepts.
Excellent communication skills with demonstrated leadership ability.

Benefits

Comp & perks

Competitive base salary and performance related incentives
Health and wellbeing programmes including medical, dental, and vision coverage where applicable
Retirement and pension plans
Life assurance and disability coverage
Employee assistance programmes and wellbeing resources
Learning and development opportunities through structured training and career pathways

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

CDISCCDASHSDTMcontrolled terminologyCRF design conceptsmetadata repositoryproject planningdata analysisprocess improvementreporting

Soft Skills

communication skillsleadership abilitymentoringcollaborationconsulting

Certifications

undergraduate degree