documents and case report forms (CRFs) in Electronic Data Capture (EDC) systems. Safety Monitoring: Monitoring patients...
) in Electronic Data Capture (EDC) systems. Safety Monitoring: Monitoring patients for adverse events (AEs) and serious adverse...
., CTMS, eTMF, EDC, eCOA, IRT). Serve as a subject matter expert (SME) for clinical systems, ensuring alignment...). Experience with clinical systems such as CTMS, eTMF, EDC, IRT, eCOA, etc. Proven track record in system implementation, process...
. Proficient in clinical systems including EDC, IVRS, CTMS, eTMF, and other clinical project management tools;ability to learn new... to manage CRO relationships and oversee data management deliverables. Strong knowledge and experience of EDC systems (Medidata...
, traceability, and inspection readiness from study startup through database lock. Design and build eCRFs and edit checks within EDC..., or decentralized clinical trials. Demonstrated experience designing and building EDC systems, including CRF development and edit check...
, ensuring accuracy (i.e., case report forms, EDC, etc.) and timely completion. Gather source documents, update patient files...
(EDC) systems. Safety Monitoring: Monitoring patients for adverse events (AEs) and serious adverse events (SAEs). Patient...
) in Electronic Data Capture (EDC) systems. Safety Monitoring: Monitoring patients for adverse events (AEs) and serious adverse...
. Current GCP certification required (or willing to obtain). COMPUTER SKILLS Experience working with EDC, eTMF, CTMS...
and informatics, including the use of Electronic Data Capture (EDC) systems. Other Requirements: Maintain compliance... and train others in EDC systems, enter data accurately, and ensure data security and provenance. Leadership and Professionalism...