and submission of case report forms (EDC), study drug/device accountability, monitoring of subjects, AE/SAE reporting, study close...
data;perform accurate EDC data entry. Prepare for and support interim monitoring visits (IMVs), audits, and inspections... system. Experience with EDC systems (e.g., Medidata Rave). Prior regulatory experience. Strong organizational and time...
capture (EDC) systems Ensure compliance with FDA regulations, ICH-GCP guidelines, and study protocols Maintain regulatory... with EDC systems Phlebotomy and/or clinical skills ACRP or SOCRA certification (or willingness to obtain...
, EDC systems, and clinical research. Share responsibility with Data Coordinators to identify lab facilities and normal lab...
clinical monitoring plan Complete source data verification of clinical study data entered in an Electronic Data Capture (EDC...
), Enterprise Data Catalog (EDC), and related tools to ensure data transparency, compliance, and trust across the organization...
, with experience in clinical trial managment/operations preferred Experience with EDC, clinical trial operational systems, regulatory...
, consolidating data across EDC, CTMS, ePRO/eCOA, imaging, and external data sources Extensive experience delivering or scaling...
Philippines, responsible for Wafer Automation Image Analytics, Metrology, Probe development, EDC, and SPC support... Automation Image Analytics, Metrology and Probe development along with EDC and SPC support. Liaison to US based Wafer IT MFG...
experience required 1-2 years of experience utilizing a CTMS, EDC, IWRS/IXRS, EHR Technical or Administrative Knowledge...