CountryStudyManager

**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