Country Study Manager

About this role

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 service providers•Develop &manage contingency risk plans to assure timely delivery to quality, budget,. and time and escalate issues to stakeholders as appropriate Lead preparation and delivery of study documents (e.g

Protocols/amendments, documents detailing study delivery data management activities, etc.), ensures operational inputs from other functions (e.g. Regulatory, Investigational Product Supply, etc.) Track and manage to agreed study time lines, budget, and resource and ensure the u date of appropriate systems (e.g. IMPACT, ACCORD) Plan, lead and ensure appropriate training is achieved at Investigator/monitor meetings Coordinate and/or contribute to timely delivery of Operations components of submissions to regulatory authorities (e.g

CSRs, annual reports) Ensure that study related decisions have

Apply for this role on AstraZeneca’s official careers site.