/ http://www.slideshare.net/images/logo.gif / ºÝºÝߣShare feed for ºÝºÝߣshows by User: ClaudeDragos https://public.slidesharecdn.com/v2/images/profile-picture.png Manages, supervised &coordinates all aspects of the clinical study to ensure respect of timelines -Designs protocols, informed consent forms, case report forms, final reports, etc. -Prepares documents for regulatory submission’s (CTA) & assembles documentation to be sent to Ethics Committees & follow-up on the progress of the approval -Assess potential investigators & sites, evaluating facilities, personnel & adherence to GCP -Oversees the activities of CROs for the conduct of studies (study guidelines, monitoring , data management, data validation, statistical analysis) -Prepares, reviews and implemets Standing Operating Procedures (SOPs) -Site-monitoring and/or co-monitoring with study ...