Senior Specialist - Risk-Based Quality Management in Clinical Trials

Senior Specialist, Risk Based Quality Management

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 promote quality, efficiency, and continuous learning, with measurable gains in signal detection and operational focus.
• Ensure CtQ factors are monitored through centralized monitoring following the Coordinated Quality Risk Management Plan (IQRMP) and study monitoring plans. Review CtQ data regularly to identify trends, potential risks, and systemic issues. Facilitate CtQ data review meetings with global study teams and share insights with local and global collaborators.
• Study Quality Risk Management Plan Support: Support—and when appropriate lead, under guidance—activities related to the Study Quality Risk Management Plan (SQRMP), ensuring risks are proactively identified, prioritized, and mitigated.
• Delivery and Collaboration: Lead delivery of specific tasks within assigned studies or CM initiatives in collaboration with CM colleagues, demonstrating accountability for timelines, quality, and inclusive engagement with collaborators.
• Advocacy and Cross-Functional Influence: Act as an advocate for centralized monitoring in cross-functional organizational activities, elevating adoption of data-driven monitoring and embedding RbQM principles across teams.

Essential Skills/Experience:

• Bachelor’s degree (or equivalent experience) in Life Sciences or a related field
• At least 2 years of experience in the biotech, pharmaceutical, or CRO industry (experience gained through a variety of career paths, including career breaks, military service, caregiving, or volunteering, is valued)
• Working knowledge of clinical research and pharmaceutical drug development processes
• Understanding of Risk-Based Monitoring (RBM), Risk-Based Quality Management (RbQM), and centralized monitoring methodologies and tools
• Strong analytical skills, including experience interpreting data trends, graphs, and charts
• Awareness of GCP and applicable regulatory requirements related to RBM/RbQM
• Project and risk management capabilities
• Effective communication and interpersonal skills, with proficiency in written and spoken English
• Ability to collaborate in diverse environments with a distributed team

Desirable Skills/Experience:

• Experience in an RbM/CM-related role
• Experience organizing or coordinating team activities
• Experience engaging with senior collaborators
• Demonstrated ability to contribute to complex, cross-functional initiatives

Why AstraZeneca:
Join an organization where scientists, data experts, and clinicians come together to turn signals into decisions that build development. We combine advanced analytics, AI and digital tools with deep biological insight to pursue treatments that prevent, modify and even cure complex diseases. You will strengthen a high-ambition pipeline while learning from patients and partners across industry and academia, working in an environment that values kindness alongside ambition and puts unexpected teams in the same room to unleash bold thinking—so your contribution reaches far beyond a single study and into the lives of people worldwide.

We are committed to building an inclusive and equitable workplace where everyone can thrive. We welcome and encourage candidates of all backgrounds, perspectives, and abilities. Flexible and hybrid working options are available depending on role and location, and we provide reasonable adjustments throughout the recruitment process and employment to support accessibility.

Call to Action:
Take the next step to lead risk-based quality that protects patients and speeds development—let your expertise turn insight into impact. If you’re excited by this role but don’t meet every requirement, we still encourage you to apply; your skills and potential may be a great fit. If you need reasonable adjustments during the application or interview process, please let us know.

Date Posted

29-Jun-2026

Closing Date

11-Jul-2026

AstraZeneca embraces diversity and equality of opportunity.  We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.  We believe that the more inclusive we are, the better our work will be.  We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.  We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

Experience Level

Senior Level