Pauline Giroud

Phase III, multi-center & international vaccine trials:  Rabies trial (Asia): Investigational products set up & Import permit - CTMS update  Japanese Encephalitis: Recruitment following-up - Investigational products: Packaging/Labeling/Shipment  Flu Pediatric trial (Europe): Feasibility studies on CTMS (Investigators database & update)  Dengue trial (French Overseas): Study documents preparation - Monitoring Plan, Operating Guidelines  Working groups: Emergency unblinding process - EC & HA submi

Phase III, multi-center & international flu vaccine trials: Trial preparation & set up management  Study documents preparation & review - Protocol, Operating Guidelines, Diary Card, Memory Aid, eCRF  Ethic Committee submissions - France  Investigators & CRAs training on trial documents & clinical tools - Investigator meeting  IVRS/IWRS randomization system & EDC (Inform 4.6) set up  Investigational products set up: packaging/labeling/shipment - Study materials: documents set up  Trial set up

Phase II & III, multi-center & international dengue vaccine trials: Trial planning, communication & budget  Trial planning set up & update on OPX2 (Compass) - Trial budget estimate on GrantPlan  Clinical team communication & coordination - Clinical trial plan monitoring – USA  Mapping process of Sanofi pasteur trial budget in France & USA

 Cardiology department - Subjects screening/enrollment (IVRS) - CRF/eCRF Data capture - Monitoring visit

Infected human blood (seasonal, pandemic & A/H1N1 flu) - BSL2+ security laboratory  Type A & B Influenza virus qualification - Blood clinical testing - ELISA & Cell line - Reports

Infected bovine, ovine & human blood (Creutzfeldt-Jakob disease) - “P3” security laboratory  Protocol optimization - Quick diagnostic on pathologic prion protein - ELISA & Western Blot

 Blood bioassays - Automatic & manual qualification - Administrative work

project Management & Clinical Operations

Professionalisation en Biotechnologies

Spécialisation en Biotechnologies

Analyses biologiques