Clinical Study Manager

Feladatok: Planning and writing of clinical investigation plans, consent form, CRF, other study documents;Preparing and/or submitting the request for approval to the ethics committee/competent authority;Direct involvement in the implementation of clinical investigations, site initiation, monitoring, study close-out;Train/Educate study staff;Monitor clinical investigation through on-site monitoring visits and source data verification/review;Ensure that the Investigator and study staff adhere to the clinical investigation plan, applicable regulations and GCP requirements;Maintains constant contact and motivate investigators, site staff and executes Investigator meetings;Management of TMF and ISF;Data collection and analysis, clinical investigation report writing;Writing of scientific publica...