I am fully educated medical doctor with 10+ yrs. research experience gained in both industries: pharmaceutical and CRO.
My experience includes various TAs, various roles (monitor, mentor, trainer, manager) and also exposure for regulatory activities (EC/HA submission and follow up in several countries) as well as audits (internal, external) and inspections. I have also experience with set up study within region (internationally) which also covered sites and vendors selection. I hold ultimate accoutability for execution of study on local level including resources and financial matters.
I lead several local study teams which consists of monitors, assistants, COAs/Lead CRA
I have also ex...