Project Related Medical/Safety Support:◇Minimize potential risk to PPD and clients by managing medical aspects of contracted tasks. This includes, but is not limited to, medical monitoring of all safety variables (AE, laboratory abnormalities, changes in patient medical status as well as inclusion/exclusion criteria, evaluation prescribed concomitant medication for protocol restrictions and unblinding requests). Scope of work also includes discussion internally with medical monitors in Japan, APAC and global and project team colleagues internally, as well as with principal investigators and clients of all medical issues during the course of a study by proper medical judgment, interpretation and decision.◇Medical review of serious adverse events.◇Ensure tasks delegated to medical monitors are properly executed. Adhere to applicable regulations and ICH guidances regarding clinical trials, regulatory documents, and safety issues. Adhere to client SOPs/directives and project specific WPDs for assigned projects. Adhere to PPD’s corporate policies and SOPs/WPDs.
1000万円~1300万円※経験に応ず
医師・歯科医師・獣医師