Isabelle Bady

• Assistance of Clinical Trial Leader / Trial Team in the execution of a phase II clinical trial according to the Clinical Development plan. Currently responsible for the coordination of 13 European countries.• Liaise with CRAs for Ethic Committee/ Independent Review Board submissions and update EC/ IRB and regulatory approvals, information and documents.• Translation coordination and Quality Control of study documents (patient tools, Patient Information …)• Responsible for leading the workflow of the creation of Clinical Research Study Agreements up to validation and involvement in budget negotiation.• Act as a central point of communication for extended Trial Team, as well as study sites and vendor personnel.• Assist CRA in distribution and collection of all the essential documents of the clinical trial , and file in Trial Master File, according to GCP and company SOPs.