À propos de Séverine
Français
Bilingue ou natif
Anglais
Capacité professionnelle complète
Expériences
- INSTITUTdesMICIRédactrice médicalenovembre 2024 - novembre 2024 (1 mois)-Review and writing of all SOPS for clinical department (regulatory, quality)-Creation of new SOPs
- CRO Excelya-Medicalwriter coordinatorjuillet 2021 - septembre 2024 (3 ans et 2 mois)-Narratives vendor coordinator/Medical writer coordinator for SANOFI-International trials ∗ Project management with CROs international ∗ Vendors oversight (budget, meeting): TCS, Cognizant ∗ Medical writer coordinator: narrative template, narrative writing quality check, study's timelines ∗ Review of narratives document: vendor's quality check of writing versus source documents∗ Review of SOP for medical writing
- CRO Excelya-ClinicalProject Managerjuillet 2018 - juillet 2021 (3 ans)-Global study manager for SANOFI-International trial in Rare Disease-Pediatric Multiple Sclerosis ∗ Project management with CROs international ∗ Vendors oversight: Covance, Neurostatus, Esms, PPD ∗ Data management oversight (eCRF cleaning, Data Base Lock oversight) ∗ Patients profiles-Medical Review
Recommandations
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Formations
- Clinical Research Project Manager trainingFORMATIS2016Clinical Research Project Manager training
- DU ExperimentationUNIVERSITY2009DU Experimentation
Compétences
Catégories
- Autre