Senior Associate, Central Monitor, Data Surveillance, Clinical Data Sciences
Core
Ensuring completeness, quality, and integrity of subject data in clinical trial databases using Risk-Based Monitoring (RBM) to support safe and effective medication use.
Role type
Senior Associate, Central Monitor (Clinical Data Sciences)
Builds
Risk-Based Monitoring systems and data quality controls for clinical studies
Domain
Clinical trials, pharmaceutical data management, regulatory compliance
Deliverable
production ML models | product features | dashboards & analysis | client delivery | infrastructure
Required skills
Risk-Based Monitoring (RBM) system setup, Key Risk Indicators (KRIs) definition, clinical trial database management, Oracle/PL/SQL, SAS, Java, relational database design, data cleaning, protocol review, ICH GCP compliance
Preferred skills
Central Monitor Program Oversight Lead experience, cross-study learning facilitation, conflict resolution, stakeholder influence
Technologies
Oracle, PL/SQL, SAS, Java, Windows Environment (Word, Excel, PowerPoint, Project)
Responsibilities
Implement global strategies for consistent and quality RBM processes; set up and test study-level RBM systems; review system outputs for signal and action management; define and maintain Key Risk Indicators (KRIs); ensure RBM system alignment with protocols and regulatory requirements; follow up with study teams for issue resolution; develop quality control documentation for RBM activities.
Seniority
Senior, hands-on IC