Esther Cabrero Sánchez Email & Phone Number

Spain

• Pre-trial or qualification visits, site initiation visits, monitoring visits, close out visits and remote visits in Spain, England & Netherlands.
• Update and maintenance of clinical systems tracking site compliance and within project timelines (CTMS, eTMF, Preclarus, iMedidata).
• Supporting the shipment process in Europe.
• Preparation, handing, distribution, filing and archiving all clinical documents and reports.
• Support FDA and EMA Clinical Site Inspection.
• Support and prepare sites for audits and FDA and EMA Inspection.

Comunidad De Madrid, España

• Co-monitoring visits (pre-trial or qualification visits, site initiation visits, monitoring visits, close out visits and remote visits). All visits performed under Risk Based Monitoring procedures.
• Update and maintenance of clinical systems tracking site compliance and within project timelines (CTMS, eTMF, IWRS, ERT/Yprime and Lablink, SafetyPortal).
• Preparation, handing, distribution, filing and archiving all clinical documents and reports.
• Distribution of materials to investigator sites and team members, as needed. Assistance with period review of study files and trial center files for accuracy and completeness.
• Execution of assigned administrative tasks to support team members with clinical trials execution (e.g. Site Specific ICF customization, site contracts follow-up).
• Attendance to project team meetings, preparation of meeting agendas and minutes, and maintenance of action item lists from meetings.

Camden Town, Inglaterra, Reino Unido

Master Of Science - Ms, Monitorización De Ensayos Clínicos

Biomedicina

Título Propio, Expert In Entrepreneurship And Innovation Project Management, English-Taught Course.