Principal Central Monitor-Romania
Centralized monitoring is an integral part of 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 Principal Central Monitor is responsible for leading the development of new tools, instruction guidelines and analyses essential for centralized statistical review of study data from study start through to study database lock. The Principal Central Monitor enables proactive identification, communication, escalation and management of risks at the study/country/site level.
More specifically, the Principal Central Monitor must:
- Lead effort on the development of new tools, instruction guidelines and analyses within the area of specialty, including complex and collaborative approaches with other functions.
- Lead the development and setup of study-specific tools, analyses, and centralized monitoring plans, ensuring that the monitoring approach is aligned with study risks, critical data, and critical processes.
- Act as the strategic and technical lead for centralized monitoring across multiple studies and for function-wide initiatives, providing direction on complex analyses, resolving escalated issues, and establishing consistent approaches and standards.
- Assist in creating tools, techniques and processes for automating risk-based monitoring tasks (data integration automation, data retrieval automation, data mapping automation, and automated report generation).
- Act as mentor as well as train new team members and junior staff.
- Identify data quality trends indicative of systematic errors and potential performance issues at study/country/site level and track evidence of issues and potential risks with support from senior team members.
- Represent centralized monitoring ...
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