Senior Associate, Central Monitor, Risk Based Monitoring
Core
Ensuring the completeness, quality, and integrity of subject data in clinical trial databases using Risk-Based Monitoring (RBM) systems.
Role type
Senior Associate, Central Monitor (Risk-Based Monitoring)
Builds
Risk-Based Monitoring systems and data quality assessment dictionaries for clinical studies.
Domain
Clinical Trials / Pharmaceutical / Data Quality
Required skills
Risk-Based Monitoring (RBM) system setup, Key Risk Indicator (KRI) definition, data quality assessment (DQA), protocol review, signal and action management, regulatory compliance (ICH GCP), stakeholder communication, issue resolution, quality control documentation.
Preferred skills
Experience as CM Program Oversight Lead, technical troubleshooting of RBM systems, cross-study learning facilitation.
Technologies
RBM systems, clinical trial databases.
Responsibilities
Develop and test study-level RBM systems; define and configure KRIs; review system outputs for signals and actions; ensure compliance with ICH GCP and SOPs; coordinate with study teams for issue resolution; maintain quality control documentation.
Seniority
Senior, hands-on IC