Sylvie GALVAIN

En résumé

Entreprises

• Hospices Civils de Lyon - Chef de Projet Recherche

  Lyon 2014 - maintenant

• DOCS international - Chef de projet clinique

  2014 - 2014 I 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

  ANTONY 2002 - 2013 Involved 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

  ANTONY 1992 - 2002 Involved 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 - 1992 Fisons 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.
  
  

Formations

Pas de formation renseignée

Réseau

• Cédric LOBJOIS

• Elodie MEILLER

• Laurence AMBROISINE

• Marie-Pierre FURRER

• Nassima BELAIDI

• Rafik ROUDANE

• Sarah ROUSSEL - MONTELEONE

• Servettaz CATHERINE

• Virginie D.