Céline Masquelier

Responsable d'une équipe de 8 chefs de projets en recherche clinique

Management d'un portefeuille d'essais cliniques internationaux

En charge de la planification stratégique (budget, ressources, délais), de la coordination opérationnelle (déploiement des protocoles, suivi des sites, qualité des données), et du respect strict des normes éthiques et réglementaires (GCP/ICH).

Communication avec les CRO et autorités.

Reporting direct au CODIR

• Leadership role for analysis and interpretation of clinical results for regulatory submissions and publications.

• Manage the process of screening, qualifying, and selecting, and contracting with investigators, sites and vendors required for conduct the studies

• Global clinical specialist overseeing all operational activities including planning, budgeting, implementing and completion of clinical trials in compliance with local and international regulatory requirements. Expert on monitoring processes, procedures, and systems. Manage assigned study sites and networks conducting phase IV protocols according to the monitoring plan including source document verification. Prepare and collect study site documents. Perform Initiation Visit and continue to train study personnel as needed on study protocol, procedures, study product handling and storage etc.