Senior Central Monitor
Core
Analyze and investigate clinical trial data at a macro-level using Key Risk Indicators (KRIs) and Quality Tolerance Limits (QTLs) to identify risks to participant safety and data integrity, acting as the first responder for study-level risks.
Role type
Senior Central Monitor (Risk-Based Quality Management)
Builds
Integrated data review plans and risk mitigation strategies for clinical trials
Domain
Clinical Research / Pharmaceutical R&D
Deliverable
Dashboards & analysis
Required skills
Clinical trial monitoring, data trend analysis, risk management, data visualization, ICH/GCP guidelines knowledge, protocol review
Preferred skills
RBQM model experience, therapeutic area expertise (Neuroscience, Oncology, Immunology, Eye Care, Aesthetics)
Technologies
eCRF, clinical data review platforms, digital health/wearables data sources
Responsibilities
Review protocols and update Integrated Data Review Plans; Provide recommendations on KRIs and QTLs during Risk Management meetings; Inspect aggregate clinical and operational data to uncover insights; Identify significant issues and emerging risks using KRIs, QTLs, and data anomalies; Document and communicate findings to cross-functional stakeholders; Support primary site monitors with relevant data insights; Participate in Health of Study and Risk Management Meetings; Contribute to the development and improvement of RBQM systems.
Seniority
Senior, hands-on IC with mentorship responsibilities
