【800～1300万円】【AstraZeneca】【R D】Associate Director Site Manageme…

【求人No NJB2218318】
■ 職務内容 / Job Description
Accountable for delivering the committed part of all clinical studies in Japan within their supervision
according to agreed resources budget and timelines complying with AZ Procedural Documents
international guidelines such as ICH GCP as well as Japan PMDA regulations.
Responsible for developing staff capabilities to achieve high level of performance and productivity
with the potential to lead and deliver studies in Japan

■Key Responsibilities
・Ensure study deliveries within agreed timelines cost/resources and appropriate quality in
terms of site management monitoring perspectives
・ Contribute to continuous improvement activities including study processes and other
procedures
・ Ensure effective clinical and operational feasibility assessments of sites level to execute study deliveries
・ Ensure quality of selection of investigators sites and SMOs （if needed）
・ Ensure subject recruitment strategy including risk management of site management and monitoring areas is performed for every clinical trial and contingency plans are in place
・ Ensure necessary actions are taken as a result of audits and regulatory inspections
・ Ensure contribution for regulatory inspections of site management monitoring areas
・ Ensure the sharing of experiences and best/bad practices in activities related to managing sites and delivery of clinical trials from site management and monitoring perspective
・ As a member of the Clinical Operations Leadership Team to contribute to the effective execution and implementation of the Japan Clinical Operations and R D strategy
・ Demonstrate accountability on the quality of deliverables from job holder’s function by confirming the process and communicating with their staffs regularly and proactively to identify the issues and potential risks that may jeopardize the quality of the deliverables and take necessary actions （e.g. review the contents training of the staffs and solving process issues etc.） in timely manner
・ Develop staff within the group to lead and deliver reliable cost effective and high quality clinical trial data optimising processes from operational site level study feasibilities through to study closures
・ Conduct Performance and Talent Management （in line with HR plans） in order to attract develop and retain the best personnel （talent base）
・ Compliance with AZ Procedural Documents international and local guidelines such as ICH/GCP and J GCP
・ Perform regular co monitoring/accompanied site visits in order to ensure staff skills and knowledge
・ Model behaviours that foster AstraZeneca’s preferred work environment including adherence to AZ Code of Conduct
・ Plan and manage workload of staffs ensuring appropriate supply of resources including use of contract staffs
・ FTE capacity planning and monitor and control workload of staffs in the group in accordance with appropriate SHE and Compliance standards