Senior Specialist, Risk Based Quality Management

AstraZeneca — India - Bangalore

Job Title: Senior Specialist, Risk-Based Quality Management Introduction to role: Ready to turn data into early signals that protect patients and raise the quality bar across clinical trials? Do you see patterns in complex clinical data and enjoy guiding teams to act on them? If you’re excited by data, collaboration, and patient impact, we welcome your application—whether your path has been traditional or non-linear. As Senior Specialist, Risk-Based Quality Management, you will deliver centralized monitoring for assigned studies and ensure full alignment with ICH-GCP R2 and our RbQM framework. You will partner early with global and local study teams, and with Centralized Monitoring Clinical Data Scientists, to set requirements, coordinate delivery, and translate insights into decisive actions that safeguard trial integrity and patient safety. In an environment where digital, data science and AI fuel decision-making from lab to clinic, your work will surface critical-to-quality signals that reduce risk and help promising medicines reach patients sooner. You will shape how studies are monitored, lead cross-functional CtQ reviews, and strengthen risk management plans—building scalable practices that influence not only individual studies but how we run trials across our portfolio. We provide supportive onboarding, training, and mentorship to help you succeed. Accountabilities: Centralized Monitoring Leadership: Lead and coordinate CM and RbQM deliverables for assigned studies, from requirement definition through execution oversight, ensuring compliance with ICH-GCP R2 and the RbQM framework to protect patient safety and trial integrity. Subject Matter Expertise and Enablement: Serve as a subject matter expert and provide accessible guidance and training on CM functionalities and outputs to global and local study teams and other stakeholders, enabling faster, better-informed decisions. Continuous Improvement: Identify and drive improvements to CM/RbQM processes to promot

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