Associate Director, Clinical Process Management job opportunity at AstraZeneca.

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DateMore Than 30 Days Ago bot
AstraZeneca Associate Director, Clinical Process Management
Experience: 5-years
Pattern: full-time
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Clinical Process Management

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loacation US - Durham - NC, United States Of America
loacation US - Durham - ..........United States Of America

At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation – ultimately providing employees with the opportunity to work across teams, functions and even the globe. Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal and work commitments while ensuring we continue to create a strong culture of collaboration and teamwork by engaging face-to-face in our offices 3 days a week. Our dedication to sustainability is also central to our culture and part of what makes AstraZeneca a great place to work. We know the health of people, the planet and our business are interconnected which is why we’re taking ambitious action to tackle some of the biggest challenges of our time, from climate change to access to healthcare and disease prevention. Clinical Operations is responsible for clear, compliant, and practical methods of operating across our clinical development portfolio. In this role, you will own and continuously improve Clinical Operations SOPs and procedures ensuring alignment to ICH-GCP (e.g., ICH E6), adoption by study teams and Clinical Research Organization partners, and inspection readiness. The role: You will lead process stewardship for a prioritized clinical domain such as Study Management, Site Management, Clinical Data Management, Biometrics, or Clinical Pharmacology. You’ll convene and lead a network of Subject Matter Experts to translate regulatory and operational requirements into procedural improvements that are clear, scalable, ICH-GCP compliant, and right-first-time. What you’ll do: Process stewardship and incremental improvements : Author, revise, and retain controlled documents (SOP, process map, guidance); deliver incremental improvements; handle change/risk logs, traceability, release notes, and training plans. ICH-GCP alignment and inspection readiness : Translate regulations and guidance into operational controls; support audits/inspections and sustain CAPA-driven improvements. Stakeholder leadership and adoption : Lead Subject Matter Expert networks; partner with Study and Site Operations, Clinical Pharmacology, Biometrics, Clinical Data Management, Quality Assurance, Regulatory, and CROs to resolve trade-offs and drive adoption. Performance and compliance monitoring : Define practical KPIs/metrics; use insights to reduce cycle time and increase right‑first‑time outcomes. Regulatory scanning and impact assessment : Monitor ICH GCP and related guidance (e.g., draft updates, agency advisories) and assess impacts on SOPs/procedures; plan and coordinate updates with SME networks. What you’ll bring: Experience : 5+ years in clinical operations or clinical development within pharma, biotech, or CRO environments, with hands-on involvement in clinical trial processes (e.g., Study Management, Site Management, Clinical Pharmacology, Clinical Data Management, or Biometrics). ICH-GCP expertise : Strong understanding of ICH E6 applied within SOPs/procedures. Process improvement : Demonstrated delivery of workflow or procedural changes with focused change control. Stakeholder management : Proven influence across study teams, QA, Regulatory, and CRO partners. Compliance and readiness : Experience supporting audits/inspections and embedding CAPA outcomes. Nice to have : Exposure to Risk-Based Quality Management (RBQM) concepts; familiarity with clinical trial systems and workflows such as CTMS, eTMF, EDC, or IRT; experience applying Lean/Six Sigma methodologies to optimize clinical processes. Impact you’ll have: Clear, usable SOPs and procedures aligned to ICH GCP Faster cycle times and higher right-first-time rates Stronger adoption by study teams and CROs, leading to better audit outcomes and sustained compliance Working model Hybrid; in-office collaboration three days per week to partner closely with clinical stakeholders and Subject Matter Expert networks. If you have clinical operations or drug development experience and a track record of improving procedures aligned to ICH-GCP, we’d like to hear from you. Are you interested in working at AZ, apply today! AstraZeneca is an equal opportunity employer that is committed to diversity and inclusion and providing a workplace that is free from discrimination. AstraZeneca is committed to accommodating persons with disabilities. Such accommodation is available on request in respect of all aspects of the recruitment, assessment and selection process and may be requested mailing AZCHumanResources@astrazeneca.com.   #Li-Hybrid Date Posted 21-Jan-2026 Closing Date 07-Feb-2026 Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.

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