Accomplished data leader with 30 years of experience across biotech companies and Clinical Research Organizations (CROs). Proven expertise in regulatory compliance, inspection readiness (FDA, EMA), data governance, and biometrics systems. Strong technical background (EDC, Computer Systems Validation, CDISC standards) combined with executive-level leadership
A strategic thinker trusted to drive change, manage merges and acquisitions, steer partnerships and lead inspection readiness programs, while keeping data quality and operational scalability at the core
End-to-end oversight of Clinical Data Management activities, from study build to database lock, with a strong focus on quality, timelines, and governance
Deep expertise in GCP, 21 CFR Part 11, GDPR, audit management, and inspection readiness (FDA, EMA), including due diligence support
System evaluation, selection, qualification, validation, and deployment, with governance models aligned across IT, QA, and Clinical teams
EDC expertise
Medidata Rave, Medrio, ClinDev, Viedoc, Inform
Data standards
CDISC, CDASH, SDTM, ADaM with quality controls
Technical stack
SQL, PL/SQL, SAS, CSV and system qualification
Connect with Sébastien and our team to discuss data governance, compliance, biometrics systems, and scalable clinical data operations
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