, and continuing review best practices · Safety reporting workflows (SAE/SUSAR notifications and timelines) · Source, EDC, and CTMS... creation, and ensure same-day EDC entry and reconciliation. 8. Communication: Serve as regulatory point of contact...
of study documentation and regulatory files, managing study binders, case report forms (CRFs), and electronic data capture (EDC...) systems. Collecting, recording, and entering data into study databases and EDC systems, performing data query resolution...
Vendor oversight and partnership management Problem solving, critical thinking and decision making Knowledge of EDC...
, including Axon Data Governance, Enterprise Data Catalog (EDC), Informatica Data Quality (IDQ), Metadata Manager, and MDM... Catalog (EDC), Informatica Data Quality (IDQ), Informatica Metadata Manager and Data Integration Hub Applicants authorized...
, EDC platforms, and internal tracking tools Support day-to-day study operations and visit logistics Liaise...
.* Responsibilities Collect and enter data into the Electronic Data Capture (EDC) system Resolve queries related to the clinical trial... of 2 years of experience in EDC data entry Training in HIPAA and Good Clinical Practice (GCP) Experience working...
applications including (but not limited to) Project, PowerPoint, Word, Excel, IVRS/IWRS, EDC, TMF Proactive and self-disciplined...
) Working knowledge of GCP (ICH E6), ISO 14155, and applicable FDA regulations Experience with electronic data capture (EDC...
Catalog (EDC), and related tools to ensure data transparency, compliance, and trust across the organization. Required Skills...
experience (site or sponsor) Knowledge of/experience with CTMS/EDC/TMF Experience with Good Clinical Practice (GCP...