Better Trials - Clinical Research, Lda

• overall site management; compilation of ec, ca & ha submissions, i.e; experience in ec and moh submission & contract negotiation, development, follow-up and termination of clinical trials at regulatory level. • prepare and coordinate the applications and approvals at regulatory authorities level for registration of new drugs, at national level (infarmed) for registration in portugal, spain and brasil. • investigator selection • site selection and initiation • monitoring through siv to close-out all in accordance with ich-gcp in portugal, spain, france and italy. • maintaining the call centre database administrator, assist crf development, database design in oracle clinical and clintrial, validation, generating and resolving queries, crf and query tracking and filing. • responsibility includes the study initiation, monitoring and close-out. • lead cra and mentor cra experience.