(Sr.) Country Study Manager - CVRM

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From AstraZeneca’s original posting

Serve as SDTL • Responsible for planning and leading the delivery of all components of a clinical study to time, cost, and quality from Study Specifications (SS) through study closeout activities and Clinical Study Report (CSR). • Form a motivated and aligned study team that delivers the study results on or ahead of time and to high quality • Contributes in steering committees, submission assembly teams, regulatory defence teams, and contribute to Advisory Boards as necessary • Prepare and deliver study level feasibility, and develop recruitment strategies, and the delivery of the approved Clinical Study Protocol • •Work with Line Managers to identify resource need and secure resources from various departments, timely form a motivated and aligned study team that delivers the study results on or ahead of time and to high quality • •Forecast and day-to-day management of study timelines, budget, materials and development of detailed study level plans and feasibility assessment • Plan and lead activities associated with audits in liaison with CA+A; contribute to regulatory inspection strategy teams as required • Participates in the negotiations and the selection process of external…