Simon Dourou
Clinical Data Manager, Sanofi
8 contacts-Data Management activities on 4 studies including 1 study using an Adaptative Seamless Design
-Annotation of Data Review report
-Leader of Data Review meeting
-SAE reconciliation
-Loaded Data reconciliation
-Data transfer specifications
-Update of clinical documents (Data Validation Plan, Annotated Case Report Form, Completion Guidelines etc.)
-Data validation
-DM process improvement
-Participation of Clinical Trial Team meeting
2010 - 2010-Feasibility studies and site selections
-Submissions to Ethics Committees
-CRO management
-Logistics of international clinical trials: product shipment, import license submission