and final), ensuring audit readiness. Coordinate with EDC and other data vendors (e.g., ePRO, IRT, central labs), ensuring... with FDA regulations and familiarity with web-based Electronic Data Capture (EDC), clinical data management systems...
. The ideal candidate has hands-on experience in electronic data capture (EDC) systems, query management, and study-level... management. Knowledge of clinical trial design and analysis issues. Proficiency with EDC programming and management (Medidata...
. The ideal candidate has hands-on experience in electronic data capture (EDC) systems, query management, and study-level... management. Knowledge of clinical trial design and analysis issues. Proficiency with EDC programming and management (Medidata...
according to protocol requirements Data and Documentation Enter clinical study data into Electronic Data Capture (EDC... guidelines Experience using Electronic Data Capture (EDC) systems Strong organizational and documentation skills Phlebotomy...
and document samples according to study protocol Data Management Enter study data into Electronic Data Capture (EDC) systems... Knowledge of ICH-GCP guidelines Experience using Electronic Data Capture (EDC) systems Strong organizational and documentation...
regulations Experience working with clinical research systems such as CTMS, EDC, or eTMF Demonstrated leadership or supervisory... Data Capture (EDC) Electronic Trial Master File (eTMF) Electronic Source (eSource) systems Microsoft Office Suite...
, transformation, and integration of clinical trial data from diverse sources such as EDC systems, labs, and wearable devices;Data...
and final), ensuring audit readiness. Coordinate with EDC and other data vendors (e.g., ePRO, IRT, central labs), ensuring... with FDA regulations and familiarity with web-based Electronic Data Capture (EDC), clinical data management systems...
systems (CRFs, EDC, etc.) within required timelines Maintain up-to-date source documents and patient records Support...
supervision Experience with numerous EDC systems Strong knowledge of GCPs, ICH guidelines, FDA and other applicable...