Risk Surveillance Lead (La Gran Via)

Major Accountabilities

• Facilitate trial protocol risk assessment across multiple cross‑functional domains (clinical, operational, data management, vendors, regulatory etc.) associated to critical‑to‑quality (CtQ) data and processes, including definition of quality tolerance limits (QTLs), evaluation of risks based on likelihood, detectability, impact, and ensuring mitigation strategy / plans are defined
• Responsible for drafting, maintaining, and archiving the study‑specific documentation of risk management activities e.g., Integrated Quality Risk Management Plan (IQRMP)
• Partners with the RBQM system configuration team to ensure risk indicators, quality tolerance limits and other analytics/visualizations are programmed and functioning per operational requirements in the RBQM system
• Conduct periodic central surveillance of the aggregate data at the study and potentially program level, leveraging available analytics/visualizations in the RBQM...