Clinical Project Manager
Armêl Plaine is an experienced professional of over 14 years in clinical investigations with medical devices. After obtaining a PhD in microbiology, Armêl joined a European CRO specialized in Medical devices (MedPass International) where she held CRA, study manager roles and headed the Clinical Regulatory department. Armêl has developed expertise on clinical investigations with high-risk devices at different clinical development stages (First-in man/Exploratory, Confirmatory to Observational Studies) and complex regulatory environment (Early Feasibility study and RCT under FDA regulation, sham control, patients in emergency situation, MD with drug or animal origin tissue) in a wide variety of medical indications. Armêl combines hands-on experience in clinical operation including start-up activities and comprehensive knowledge of clinical investigation.