Associate Director, Clinical Process Management
Share
Job Location:
Durham, NC - USA
Monthly Salary:
Not Disclosed
Posted on:
8 hours ago
Vacancies:
1 Vacancy
Job Summary
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 were 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 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. Youll 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 youll 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 rightfirsttime 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 youll 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 youll 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 wed like to hear from you.
Are you interested in working at AZ apply today!
AstraZenecais 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
#Li-Hybrid
Date Posted
21-Jan-2026Closing Date
07-Feb-2026Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and 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.
Required Experience:
Director
Key Skills
- Portfolio Management
- Wealth Management
- Financial Services
- Hybris
- Microsoft Word
- Banking
- Cash Management
- Data Management
- Microsoft Powerpoint
- Securities Law
- Microsoft Excel
- Internet Of Things
About Company
AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, ... View more
