Central Monitor-India
Core
Conduct holistic centralized statistical review of clinical trial data to identify risks, trends, and outliers using analytics and statistical methods.
Role type
Central Monitor (Clinical Research)
Builds
Risk-based monitoring strategies and data quality assurance for clinical studies
Domain
Clinical Research / Biopharmaceuticals
Required skills
Centralized statistical monitoring, Risk Based Quality Management (RBQM), Clinical trial database systems (EDC, IRT, CTMS), Advanced MS Office, Descriptive statistical analysis, Clinical study management processes, Regulatory operations knowledge
Preferred skills
Trial management systems, Data management systems, Good Clinical Practices (GCP), Health Canada and FDA regulations
Responsibilities
Review operational and subject data using analytical tools, Identify data quality trends and potential performance issues, Document review results per procedures, Support risk characterization and reporting, Manage workload across multiple functions
Seniority
Mid-level, hands-on IC
