INSERM SC 10 Clinical Trial Unit
- Clinical Research Manager
2005 - 2010National and international clinical trials (all phases) in infectious diseases (HIV, Hepatitis, Sepsis, Meningitis)
Management and coordination of all European clinical sites participating in 2 clinical trials in neonatology.
- Site initiation visits in all participating sites
- Coordination of sites (clinical site, pharmacy, laboratory)
- Supervision of submissions to regulatory authorities and ethic committees, budget establishment
- Protocol finalization, informed consent form writing
- Supervision of e-CRF conception and all study procedures and tools
- Study drug tracking, specimens’ shipment, SAE notification, MedDRA coding, procedures and study documents writing
- Coordination and management of dedicated team : data managers, local CRA supervision and training
- Communication with sponsor : reporting, timelines and progress (teleconferences, face-to-face meetings)
- Cooperation with statistician for data analysis
- Presentation of results to scientific committees
Languages: French (mother tongue), English, Italian and Spanish
INSERM SC-10
- Clinical Research Associate
2002 - 2005* Phase III international clinical trial – HIV infection (180 patients – 48 sites):
- Monitoring (follow-up and close-out visits) of French, Spanish and Portuguese sites
- Data capture and queries’ resolution
