Entreprises
Freelance Clinical Research Consultant
- Senior Clinical Research Consultant
2004 - maintenant
• More than 14 years of experience in clinical trials from phase II to IV & observational survey:
- Start-up activity (feasibility, budget /contract negotiations)
- Regulatory activity (EC submission, AFSSAPS and CNOM submission)
- Monitoring activity (site initiation, monitoring and close-out)
- Project management / Coordination of the sites activities (clinical department, Pharmacy, peripheral department)
- Coordination of adverses events reports as well as the safety reports
Skills :
International and national studies
Phase I, II, III, IV
Spécialités
Therapeutic areas :
Alzheimer
Cardiology / Vascular Diseases
Dementia
Dermatology
Endocrinology
Medical Device
Medically Reanimation
Metabolism
Nephrology
Neurology
Nutrition
Oncology
Ophthalmology
Psychiatry
Pulmonary / Respiratory Diseases
Rheumatology
Training :
2004 : Operational formation to the profession of CRA (Clinact)
2010 : The key of management (CEGOS)
GCPs, “Guidelines” ICH E6, data management and pharmacovigilance
e-CRF & Tools experience (Oracle, Rave, Inform, Impact, Unithink, DataMagic, Macro, CTMS)
Formations
Pas de formation renseignée