Personal Information
Organization / Workplace
Brussels Area, Belgium Belgium
Occupation
CLINICAL /SCIENTIFIC MANAGER
Industry
Medical / Health Care / Pharmaceuticals
About
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 ...