Principal Central Monitor-Romania
Core
Lead the development of new tools, guidelines, and analyses for centralized statistical review of clinical study data to identify risks, trends, and outliers.
Role type
Principal Central Monitor (Risk-Based Monitoring)
Builds
Study-specific monitoring tools, automated risk-based monitoring tasks, and centralized monitoring plans.
Domain
Clinical Research / Dermatology / Rheumatology
Required skills
Central statistical monitoring, Risk Based Quality Management (RBQM), clinical trial database systems (EDC, IRT, CTMS), descriptive statistical analysis, data quality trend identification, cross-functional risk assessment, mentorship, project protocol management.
Preferred skills
Experience in clinical monitoring, data management, drug safety, medical monitoring, biometrics, or project management.
Technologies
MS Office (Word, Excel, PowerPoint), interactive computer systems and tools, trial management systems, data management systems.
Responsibilities
Lead development of new tools and instruction guidelines for centralized monitoring; Act as strategic and technical lead for monitoring across multiple studies; Assist in automating risk-based monitoring tasks; Identify data quality trends and potential performance issues; Represent monitoring in cross-functional risk assessment meetings; Mentor and train new team members.
Seniority
Principal, strategic and technical lead with mentorship responsibilities.