Manager, Central Monitoring (Florencio Varela)

OverviewParexel FSP is looking for Manager, Central Monitoring in Argentina Candidates must have at least 7 years of overall experience and minimum 1 year directly in Central Monitoring. Job SummaryThe Manager, Central Monitoring is accountable for centralized monitoring activities for general and/or complex trials, analytical data review of key risk and/or operational performance data and presenting as an integral member of the Clinical Study team for clinical development studies. The reviews include interpretation of Key Risk Indicator (KRI) and/or Key Performance Indicator (KPI) data housed in an analytical tool as well as a comprehensive review of supplemental operational data/trends and issues to be interpreted, reported and presented to the study teams. The Manager, Central Monitoring, will be responsible for supporting several studies within a therapeutic area and program-level. They will work closely with other Central Monitors and Centralized Data Risk Analysts (CDRAs) to ensure effective identification, conduct and reporting of central monitoring activities. This role will contribute to continued process improvement and innovation activities, and industry collaborations in central monitoring capabilities. Job Responsibilities
- Collaborate on Study Quality Risk Assessment: Participate in the development and refinement of the Study Quality Risk Assessment and Control Tracker (QRACT) to identify and manage study risks.
- Develop and Author the Central Monitoring Plan: Lead the creation of the Central Monitoring Plan, ensuring alignment with study-specific needs and Risk Based Quality Management (RBQM) methodologies.
- Oversee Central Monitoring Execution: Work with data analysts to configure, implement, and execute the Central Monitoring RBQM system across assigned studies, ensuring effective signal detection.
- Analyze and Interpret Data Trends: Conduct study-level Central Monitoring Reviews using data analysis tools, interpret KRIs/KPIs, and assess trends Postúlate en Kit Empleo: kitempleo.com.ar/empleo/qguh8