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...