Associate Director, Clinical Process Management

AstraZeneca • Durham, NC

1d • Hybrid

About The Position

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.

Requirements

• 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 Haves

• 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.

Responsibilities

• 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 This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: No Education Listed
• Number of Employees: 5,001-10,000 employees