Senior Manager, Pharmacovigilance ICSR Intake - AI Enablement
. Ensure effective and compliant ICSR transmission between intake systems, call centers, EDC systems, partner organizations...
. Ensure effective and compliant ICSR transmission between intake systems, call centers, EDC systems, partner organizations...
attention to detail and degree of accuracy Familiarity with electronic data capture (EDC) systems Operates both as a team...
(such as with IRB, FDA, CAP/CLIA etc). Familiarity with Electronic Data Capture (EDC) platforms and Trial Master File (TMF... with Electronic Data Capture (EDC) platforms and Trial Master File (TMF) setup and validation. Experience Metadata Statistical...
standards. Maintain accurate, timely, and high-quality documentation in source records and EDC systems. Contribute...
to) Project, PowerPoint, Word, Excel, IVRS/IWRS, EDC Extensive experience in global clinical trial operations with unique...
effectively in a team environment and manage multiple priorities. Experience with EDC systems and electronic submission standards...
have been received prior to study initiation Completes Sponsored protocol training including (GCP, EDC, IVRS, IRB...
to) Project, PowerPoint, Word, Excel, IVRS/IWRS, EDC Extensive experience in global clinical trial operations with unique...
, Axon, and EDC is a plus. Experience in administering, configuring, and maintaining Denodo Platform environments...
and regulatory requirements. Experience with clinical databases, electronic data capture (EDC) systems, wearables, and sensors...