Mes compétences :
Essais cliniques
Gestion de projet
Entreprises
Adocia
- Clinical Trial Manager
Lyon2015 - maintenantDiabetes therapeutic area
Phase 1 to Phase 3
Management of Clinical Trials: preparation, conduct and closure
Sanofi Pasteur
- Clinical Trial Manager
Lyon2012 - 2015Flu vaccine
European Phase 4 study for new EMA guideline, adults and children
Phase 3 study with short timelines – France
European Phase 3 study
Vaccine for Nosocomial disease
European Phase 3 study
Clinical trials preparation, conduct and closure:
- Sites selection
- Study documents writing & review
- Ethics Committee submission
- Coordination of sites, CROs & CRAs
- Management of vaccines & supplies
- Strong interaction with other departments
- Study follow-up
- Quality Control visit
- eTMF & eCRF use
Transversal activities:
- Mentoring of new CTM
- Participation on a working group for quality document review for harmonization of clinical processes
- User acceptance Testing of new eCRF tool
ICTA (International Clinical Trials Association)
- Clinical Research Associate trainee
2012 - 2012Hepatitis C
International observational study - 30 countries, 300 sites, 4000 patients
Metastatic colorectal cancer
Observational study - France, 200 sites, 4000 patients
- Sites selection
- Financial agreements review
- Study site documents management & TMF
- Inclusions & study follow-up
- Monitoring office based
- Participation in several monitoring visits
CHRU Saint-Eloi Montpellier
- Clinical Research Associate trainee
