Mes compétences :
Recherche clinique
Industrie pharmaceutique
Entreprises
Hospices Civils de Lyon
- Chef de Projet Recherche
Lyon2014 - maintenant
DOCS international
- Chef de projet clinique
2014 - 2014I was in charge of an international trial on vaccines in Sanofi Pasteur MSD. I had to manage the CRO mandated for monitoring. I was the interface with the SPMSD study team (Data manager, Biostatistician, Regulatory and Pharmacovigilance Officer).
Stallergenes
- Chef de Projet Clinique
ANTONY2002 - 2013Involved in phase I to III clinical trials in allergy field.
Responsible for trials (deadlines, logistic, quality, budget...)
Management of CRO and CRO activities assessment (monitroing, central lab, regulatory, pharmacovigilance, Biometry...).
Participation to CRA training and comonitoring.
Review of the documents (protocol, CRF, ICF, report, publication...)
TMF audit management.
Adverse events reports review
Data coding with MedDRA dictionnalry review.
Interactions with Regulatory affairs, Quality assurance, Medical writing, Pharmacovigilance, Purchase department, Legal department.
Stallergenes
- Assistante Recherches Cliniques
ANTONY1992 - 2002Involved on phase II and III clinical studies in allergy field (respiratory allergy to pollen , house dust mite; allergy to latex).
Site selection, Site Initiation, monitoring and closeout visit.
Protocol and CRF writing.
Management of CRO
Standard Operating Procedures writing
FISONS SA
- Assistante Recherches cliniques
1986 - 1992Fisons was an english pharmaceutical company manufacturing cromones (Cromoglycate, nedocromil).
Involved on phase III clinical studies in allergy field (asthma/rhinitis).
Site selection, Site Initiation, monitoring and closeout visit.