NICE
- More than 20 years experience in Clinical Research (Pharma, Biotech and CRO)
- Recruitment and Team management (CRA, CTA, Lead CRA, Project Manager)
- Management of international trials (Europe, China, Brazil) in various therapeutics area (Oncology, Psychiatry, Cardiology, Metabolism, Rheumatology, Pediatry, Gastroenterology, Pneumology, Dermatology)
- CRO Management and implentation of a FSP partnership with preferred provider (RFP, budget, KPI, quality assesment visits)
- Writing of scientific documents (protocol, ICF, CRF, IB, newsletters, Orphan Drug Report, Annual Safety Report...)
- Monitoring of phase 1, 2 and 3 in various therapeutic areas : Psychiatry, Cardiology, Metabolism, Gastroenterology, Rheumatology, Dermatology, Prostate cancer, Pediatry
- Training of Clinical and Data Management Team
- Quality approach : writing and management of SOPs following regulatory requirements, audits, CA/PA, validation of IT system in Data Management
Mes compétences :
Recherche et développement
Recherche clinique
Gestion de Projet
Management, encadrement d'équipe