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Sanofi Pasteur
- Clinical Trial Manager
Lyon
2016 - 2017
Projects
Clinical Trials – International (Poland and Russia)
• Meningococcal Vaccine
o Observational Study in Russia, prospective safety study
o Phase III Study: Immunogenicity & Safety Study in Europe
• Pediatric combined vaccine – Immunogenicity & Safety (registration) Study in Russia and Poland
Responsibilities
• Feasability/Site selection,
• Submission to HA/EC preparation,
• Coordination of sites, CROs & CRAs,
• Management of vaccines & supplies,
• Strong interaction with other departments, Study follow-up, eTMF and eCRF use
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Sanofi Pasteur
- Clinical Program Manager
Lyon
2015 - 2016
Projects:
Clinical Trials – International (Asia, Latin America)
• Dengue Project – Exploratory Phase (Epidemiology/Thailand), Phase II (Immunogenicity & Safety/Brazil)
• Clostridium Difficile Project – Phase III (Efficacy, Immunogenicity & Safety/Asia)
Responsibilities:
• Coordination of clinical trials and study-related activities (monitoring, data management,
regulatory affairs, biostatistics);
• Management of negotiation and budget (AED, Investigator agreement, fee negotiation and payment of the investigators/centers);
• Management of planning of the studies, communication of timelines and studies progress
• Organization and chairing of clinical team meetings
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Sanofi Pasteur
- Clinical Project Manager V.I.E (Singapour)
Lyon
2013 - 2015
Management and coordination of the projects:
• Epidemiological Studies – International (Asian region)
o Prospective dengue incidence study in India, involving 14,000 subjects / 4 sites
o Dengue Seroprevalence Study in Indonesia – 3200 Subjects / 1 main site - 30 satellite sites
o Incidence Study in Dengue-Endemic region in Asia and Latin America – Coordination for activities in Asia – 5 sites in Malaysia
o Vaccine safety and effectiveness studies to prepare for dengue vaccine launch in Malaysia and Philippines - 2400 Subjects / 7 sites
• Clinical Trials – International (Vietnam) - Registration of Meningococcal Vaccine in Vietnam – 200 Subjects
• Investigator Sponsored Studies – International (Asian Region) - Working on several projects (Flu, Clostridium Difficile, Meningococcal, Pertusis..)
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Sanofi Pasteur
- Clinical Program Manager - Apprentice
Lyon
2012 - 2013
Projects:
Clinical Trials – International (Asia, US)
• Dengue Project – Phase I (Tolerance/Philippines), Phase II (Immunogenicity & tolerance/Singapore + two trials in collaboration with the US Army), Phase III (follow-up of subjects included in efficacy trial/Thailand)
• Support for Quadrivalent Flu Vaccine trial
Responsabilities:
• Participation at coordination of clinical trials within a project
• Management of budget of the studies (AED, Investigator agreement, fee negotiation and payment of the investigators/centers)
• Management of planning of the studies, communication of timelines and studies progress
• Coordination of study-related activities: monitoring, regulatory affairs, data management and biostatistics
• Organization and chairing of clinical team meetings
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ICM, Institut du Cancer de Montpellier
- Attachée de Recherche Clinique - Stagiaire
montpellier
2012 - 2012
- Management d'une Etude de Phase II sur le cancer du Rectum
- Management d'une Etude de Phase II sur la chirurgie conservative dans le cancer du sein (oncoplastie)
- Suivi de patients
- Mise en place d'une Etude
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ICM, Institut du Cancer de Montpellier
- Attachée de Recherche Clinique - Stagiaire
montpellier
2012 - 2012
- Particiapation en tant qu'Attachée de Recherche Clinique sur une étude de Phase I en oncologie
- Suivi de patients
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Institute of Technology Tallaght (Dublin, Irlande)
- Stagiaire recherche fondamentale
2011 - 2011
- Suivi de protocoles expérimentaux
- Synthèse de nouveaux produits (polymères)
- Utilisation des méthodes de caractérisation électrochimique
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Inserm
- Attachée de Recherche clinique - chercheur (stagiaire)
PARIS 13
2010 - 2010
- Participation en tant qu'ARC à une étude clinique sur la Dystrophie Facio-Scapulo Humérale
- Travail en laboratoire, suivi de protocoles expérimentaux
