Mes compétences :
CRO
Oncology
ICH-GCP
CTMS
Coordination
Pharmaceutical industry
International
SOP
SAE
Clinical Trials
Entreprises
Pierre Fabre
- International Clinical Study Coordinator
Castres2004 - maintenantPhase III study in breast cancer for registration in China (since 2013)
- Set up activity in China with 1 CRO
- Responsible for SAEs (analysis, tracking, periodic review)
- Responsible for SOPs implementation
- Responsible for study deviation (periodic review, follow up of CAPA implementation)
- Responsible for oversight of the CTMS
- Involved in drafting study documents
Phase III study in breast cancer for registration in Europe (since 2006)
1000 patients all over the world,
- Responsible for study activities conducted in 3 countries Pierre Fabre affiliates (France, Belgium, Portugal and 1 country handled by a CRO (India)
- Presentation and organization of study meetings with investigators and CRA
- Follow up of all the monitoring activities
- Development of tools to track IPs
- Involved in drafting SOPs (IP, SAE, monitoring, study deviations)
- Validation of clinical data (446 patients)
- Closing out activities
Phase III study in lung cancer (since 2004)
- Writing 170 SAE narratives
- Closing out activities
Pierre Fabre
- Clinical Research Associate
Castres2001 - 2004- Therapeutic area: prostate cancer, lung cancer, mesothelioma...
- Phase: I, II and III
Pierre Fabre
- International Clinical Study Coordinator
Castres2001 - 2001- Therapeutic area: lung cancer
- Phase : II
AstraZeneca
- Clinical Research Associate
Rueil-Malmaison 2000 - 2001- Therapeutic area: lung cancer
- Phase: II and III
Pierre Fabre
- Clinical Research Associate Trainee
Castres2000 - 2000- Therapeutic area: prostate cancer, lung cancer and myeloma
- Phase: II and III