Mes compétences :
Industrie pharmaceutique
CRO
Ethic
GCP
ICH
International
Start up
Entreprises
MEDPACE
- Regulatory Submission Coordinator
2014 - maintenant
Parexel
- Clinical Trial Specialist
Paris2012 - 2014
Icon Clinical Research
- Study Start Up Associate
2011 - 2012
Kendle International Sarl
- Clinical Regulatory Specialist - Study Start Up
2008 - 2011* Preparation of submissions to Competent Authorities (CA) and Ethics Committee (EC) (Study start up and amendments)
-> Adaptation and review of study documents and forms according the local regulations, (including subject information sheet and informed consent form)
-> Local contact for CA and EC,
-> CNOM submissions (Contracts, Investigator meetings, …),
-> CCTIRS – CNIL submissions for non-interventional studies
-> since 2011: CIL function - correspondent between the French Data Protection Authority (CNIL) and my company
* Local consultant on specific regulatory items.
* Medical domains:
Allergology, Andrology, Dermatology, Gastroenterology, Haematology, Infectious diseases, Medical genetics, Neurology, Ophthalmology, Oncology, Paediatrics, Rheumatology, Sexology, Urology...
