Mes compétences :
BPC
BPL
Monitoring
BPF
Contrôle qualité des données
Parasitologie
Entreprises
Merial
- Clinical Research Associate - Pharmaceutical Clinical R&D
Lyon2011 - maintenantProvide support and assistance for Pharmaceuticals Clinical R&D studies submitted to regulatory agencies including FDA and EMA.
Study organization, conduct and reporting, and perform quality control of study data and reports in compliance with GLP or GCP across multiple Clinical R&D projects:
- Administration and technical support of clinical studies
- Management of subcontracted studies for both clinical and non-clinical phases
- Monitoring and coordination of field trials
- Study protocols and reports writing & review
- Quality Control of studies
- Awareness of Animal Welfare requirements
- Health, Safety & Environment compliance
Knowledge and skills: excellent oral and written communication in French and English, well-developed organizational, ability to multi-task high scientific rigor and ability to comply to regulatory and quality requirements.
PHATOPHY
- Directeur d'Etude Préclinique
Marcy-l'Étoile2009 - 2011Études réglementaires et/ou de développent sur les propriétés pharmacologiques et pharmacocinétiques des médicaments vétérinaires en conformité avec les BPL
- In-life (Plans d’Étude, MOP, Rapports).
- Phases analytiques (Dosages, analyses HPLC)
- Dossiers réglementaires (résumés tabulaires)
MDS Pharma Services / Ricerca
- Technicien Animalier Intermittent
2008 - 2009Études réglementaires
Weekend et vacances scolaires
