Paris, Île-de-France, France
. 14 years of experience in pharmacovigilance Processing of postmarketing non serious and serious ISCR (all types) from reception to submission and archiving, signal detection (including off label use) activity, on-call duty, training of new comers, management of subcontractors. .12 years of experience in Clinical Data Management from database set-up to database lock. Coordination and implementation of all data management activities from protocol synopsis to submission (e.g. DM Plan, eCRF design (RAVE), database and data validation specifications, user acceptance test (UAT), query management, database lock, training).
Processing of postmarketing non serious and serious ISCR from reception to archiving Ensure compliance of PMS case submission Submission of clinical trials case to Health Authority Handling of the SafetyLuFrance mail box PV reconciliation cases Signal detection including off-label activity PV training for new comers Participation in audits/inspections Management of subcontractors
Member of the study management team Management of several phase II and III studies (300 patients on average) in the neuropsychiatry area: depression, GAD, schizophrenia. • Before the FVFP: o Creation of all the documents needed for the eCRF setup: CRF/eCRF specifications Validation specifications o Development of validation tool to do the uat of the database • After the FVFP: o Data validation including queries creation o Organization of clinical data review meeting o Participation in project meetings o Ensure database lock within the given timelines o Membre of the SMT (Study Management Team) Participation in writing quality documents: procedures, standards documents.
Statistical analysis of an international survey about the perception of cotton fiber quality for CIRAD-CA URBI de Montpellier (Centre de coopération International en Recherche Agronomique pour le Développement – Cultures Annuelles Unité de Recherche Biométrie Informatique).