Description
I supervised the development of several clinical projects in different therapeutics areas and in different countries (France, England, Italy, USA and Canada). I coordinated the clinical activities in respect with the budget, timeframe and regulations (SOPs, FDA-GCP and ICH guidelines). I trained CRAs, site investigators and CROs to ensure study protocol comprehension and compliance (initiation visits, co-monitoring). I planned priorities and implemented preventive actions to conduct with success all trials. I developed and reviewed study documents (protocol, CRFs, study manuals…). I designed electronic CRF and verified clinical data. I interacted with the different clinical partners for the transmission of study updates and issues (organization of teleconference). I wrote statistical reports in order to bring additional information for the study final report. I set-up and followed study budgets. I collaborated with the Quality Control department to ensure high quality services.
