Responsible for 3 international studies, from phase II to III ( HIV infection ) for France, Switzerland, belgium, Spain, Brazil, Roumania, Denmark, Portugal, Uganda, Thailand, Italia, England, Polonia)
- Medical department support for Regulatory Authorities submission; Monitoring activities (selection, initiation, monitoring and termination),
TMF maintenance, update of regulatory documentation
- Master trial file.
Mes compétences :
BPC
ICH