Clinical Study Administrator

**Clinical Study Administrator**:**Location: CDMX****Hybrid work - 3 office days**- Interfaces with Investigators, external service providers and CRAs during the document collection process to support effective delivery of a study and its documents.- Operational responsibility for the correct set-up and maintenance of the local eTMF and ISF including document tracking in accordance with ICH-GCP and local requirements.- Ensures essential documents under their responsibility are uploaded in a timely manner to maintain the eTMF "Inspection Readiness".- Ensures that all study documents are ready for final archiving and completion of local part of the eTMF and supports the CRA in the close out activities for the ISF.- Coordinates administrative tasks during the study process, audits and regulatory inspections, according to company policies and SOPs.- Leads the practical arrangements and contributes to the preparation of internal and external meetings e.g., study team meetings, Monitors' meetings, Investigators' meetings. Liaises with internal and external participants and/or vendors, in line with international and local codes.- Prepares, contributes to and distributes presentation material for meetings, newsletters and websites.**Essential Skills**- Bachelore degree- English - Basic/Intermediate- Excel - Intermediate/advanced