Centralized Monitor
Core
Performs review and analysis of centralized, aggregated data to identify potential signals and trends in predefined risk indicators for clinical studies.
Role type
Centralized Monitor (Clinical Research)
Builds
Risk assessments and quality monitoring outputs for clinical trials
Domain
Clinical Research / Life Sciences
Deliverable
dashboards & analysis
Required skills
Risk Based Quality Management (RBQM), centralized monitoring principles, clinical study data interpretation, regulatory knowledge (ICH-GCP), analytical skills, problem-solving
Preferred skills
Knowledge of Risk Assessment and Categorization Tool (RACT), RBQM system usage, site-level Key Risk Indicators (KRIs) review
Technologies
RBQM system, RACT
Responsibilities
Review and analyze centralized aggregated data to identify risk signals and trends; Support initial review of the Risk Assessment and Categorization Tool (RACT); Review outputs from the RBQM system and escalate findings; Conduct periodic review of site-level Key Risk Indicators (KRIs); Monitor site performance and identify issues requiring corrective action; Evaluate quality and integrity of study site practices regarding protocol compliance; Maintain project-level communication with stakeholders regarding monitoring findings; Maintain project documentation and contribute to centralized monitoring documentation.
Seniority
Junior, hands-on IC
