À propos de Sabrina
Senior consultant specialized in clinical trial regulations and submission strategy. Starting as CRA, growing in different structures (CROs, Oncology center) with almost 20 years of experience in the pharmaceutical and biotechnological industries. Extensive expertise in oncology and experience in rare disease, at international level.
Français
Bilingue ou natif
Anglais
Capacité professionnelle complète
Accepte de travailler sur site
Toulouse (jusqu’à 50 km)
Expériences
- AllucentGlobal Regulatory LeadSECTEUR MÉDICALjuillet 2023 - janvier 2025 (1 an et 6 mois)France
- Plan timelines for RA/IEC/IRB submissions in 19 countries (US, Canada, EU (CTR), Moldova, Ukraine, Georgia, UK, LATAM)
- Coordinate the preparation of submissions
- Ensure appropriate tracking is done on time
- Review and finalize Master SIS/ICF
- Oversee Country SIS/ICF.
- AllucentGlobal Submission SpecialistSECTEUR MÉDICALjanvier 2022 - juin 2023 (1 an et 5 mois)Netherlands
- Perform CA and EC submissions in Europe under CTR (AT, DE, FR, IT, ES) and CTD (FR, UK, ES, DK, AT, DE, BE, NL).
- Create Master and country ICF.
- Acting like SSUM for small studies.
- Reviewer of SOPs
- IQVIA BiotechRegulatory and Start-Up SpecialistSECTEUR MÉDICALjuillet 2019 - décembre 2021 (2 ans et 5 mois)France
- Perform site identification and Feasibility
- Adapt country ICF
- Prepare and submit CEC packages
- Advice Regulatory for submissions
- Submit CNIL notification
- Create National Grid and negotiate Contract Unique (CU) and other agreements with all sites
- Submit CU to CNOM via IDAHE2
- Collect Essential documents
- Perform QC of CEC/LEC packages for EU countries
- Lead French LSSU on some studies
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Formations
- Master of Clinical Research AdminSup2006Clinical Research Associate Training
- MSc in Analytical Chemistry and Quality AssuranceUniversity of Orléans2004MSc in Analytical Chemistry and Quality Assurance