Central Monitor-India

Description ​​Centralized monitoring is an integral part of a risk-based monitoring strategy, defined as the timely, remote review of accumulating subject and operational data to help distinguish between reliable and unreliable data, trends, outliers, and unusual variability using analytics and statistical methods. The central monitor is responsible for conducting a holistic and centralized statistical review of study data from study start through to study database lock according to the centralized monitoring plan, using analytical tools to identify emerging and existing risks to critical study data and process. The central monitor enables proactive identification, communication, escalation and management of risks at the study/country/site level. ​ RESPONSIBILITIES ​​Follow established procedures for the review of clinical trial data (Operational and Subject data) using a variety of tools and systems in alignment with the centralized monitoring plan and with support from the senior team members. ​Identify data quality trends indicative of systematic errors and potential performance issues at study/country/site and track the evidence of issues and potential risks with support from senior team members. ​Ensure results of reviews are appropriately documented per procedures. ​Support Central Monitoring teams with performance of assigned reviews with high quality, on-time results. ​Provide input to senior team member as needed to support development of risk characterization and re