Job Description

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...

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