Description

Clinical Operations Consultant with 15+ years of experience in international clinical research, particularly in oncology and multicenter Phase I–IV studies.

I support sponsors and CROs with study coordination, operational oversight, CRA management, ICH-GCP compliance, and Clinical Trial Management support activities.

Recognized for my professionalism, strong organizational skills, and ability to collaborate effectively with international teams, I am also appreciated for my communication skills, diplomacy, adaptability, and collaborative mindset.

Autonomous, detail-oriented, and highly committed, I place strong emphasis on quality, communication, and meeting timelines.

Available for remote / home-based freelance assignments in Clinical Operations.

Domaines d’expertise

Langues

Français
Bilingue ou natif
Anglais
Capacité professionnelle complète
Allemand
Notions

Préférences en matière de lieu de travail

En télétravail uniquement

Travaille majoritairement à distance

TRIO Oncology,
Global Clinical Trial Manager – Freelance
SECTEUR MÉDICAL
février 2020 - février 2025 (5 ans)
France
• Led country and site oversight activities across Phase I–III oncology studies in France, Belgium, United Kingdom, Hungary and South Korea.
• Led and mentored CRAs across multiple countries (Asia, UK and Europe), ensuring monitoring quality, GCP compliance and timely issue escalation.
• Review of monitoring reports, deviations, and CAPAs (GCP compliance)
• Coordinated regulatory submissions across EU and the UK
• Enhanced TMF quality and ensured inspection readiness
• Managed vendor relationships and supported financial reconciliation
• Organized investigator meetings and contributed to CRA training materials
• Contribution to SOP revisions and CRA training materials
Clinical Trial Management GCP Compliance Regulatory Affairs Financial Oversight Inspection Readiness
Freelance | TRIO Oncology,
Senior Clinical Research Associate
août 2016 - mars 2020 (3 ans et 7 mois)
France
• Managed up to 15 sites and 75+ patients in Phase II–III breast cancer studies
• Conducted monitoring visits, SDV, SAE reporting, and IMP accountability
• Collaborated with cross-functional teams (PM, DM, PV, QA)
Covance
Senior Clinical Research Associate
octobre 2014 - juillet 2016 (1 an et 9 mois)
France
• Led site monitoring for Phase I–III studies in oncology and neurology
• Supported study start-up activities and site initiation
• Ensured protocol compliance and data quality across multiple sites