Elisa BAELEN

• CLINICAL TRIALS MANAGER - Phase IV / Post-marketing studies
- Design of the Protocol (closely with Medical Director), CRFs, ICF
- Study feasibility assessment
- Budget and timing evaluation and follow-up
- Submission and preparation of documents to authorities (IRB/IEC)
- Sites selection and investigators recruitment
- HCPs training meetings organisation and animation
- Contact point for the internal and external clinical studies members
- On-site monitoring visits (opening, follow-up and closure visits): Oversee progress of trials (record and report in accordance with protocol, SOPs, GCP)
- Knowledge of ICH/GCP
• Development of European medical education program for HCPs
- KOL’s selection and collaboration
- Interactive programs development and follow-up

collaboration au développement d'un nouveau portai informatique

mise en place d'une production d'anticorps polyclonaux

controle qualité chimie produits semi-ouvrés, matières premières et produits finis

--> culture cellulaire
--> établissement de caryotype à des fins de recherche