Senior V2V Process Specialist I

Typical Accountabilities
Support establishing study and trial level V2V process. Support developing V2V related study and trial documents, creating apheresis and product administration manuals and forms and ensure documents are
product specific and consistent across all active trials.
• Responsible for providing training to AZ study team members. Coordinate with internal teams and cell therapy site staff to ensure all site onboarding activities are successfully completed and sites are prepared
to support within the required timelines. Support rollout of process changes.
• Support day-to-day operations of cell therapy trials, e.g., scheduling, communication with involved parties, logistics management, etc., and lead issue solving related to V2V process. Conduct planned quality check on established V2V process of ongoing trials. Support clinical site staff by participating in deviation activities and impact/investigation assessments.
• Work with Quality Assurance and other internal team members (e.g., clinical team, etc.) to monitor and assess vendor performance and capacity.
• Support developing, maintain, and evaluate key performance indicators (KPI) for patient treatment execution. Monitor progression of KPIs, identify potential risks, conduct necessary investigation, lead required actions, escalation, and manage communication with relevant stakeholders.
• Work with line manager for team working process development, optimize and digitalization according to business needs.
• May take other cell therapy related activities, assigned by line manager.

Qualifications and Skills
Essential Desirable
• Bachelor degree or above in healthcare-related field, or equivalent.
• At least 4-year experience as CTA/CRC/CTC or equivalent experience, with experience in cell therapy clinical operations.
• Knowledge in clinical study process and understanding of the ICH/GCP guideline.
• Team oriented and flexible, ability to respond quickly to shifting demands and opportunities.
• Good interpersonal skills and ability to work in an international team environment.
• Demonstrates ability to prepare and deliver study related training materials.
• Ability to train others on study administration procedures.
• Have organization and time management skills.
• Good computer skills in Microsoft and other software. Ability to develop advanced computer skills to increase efficiency in day-to-day tasks.
• Proficient written and verbal communication skills, collaboration and interpersonal skills.
• Proven organizational and administrative skills.
• Fluent in both oral and written English.
• Excellent attention to detail and good ability to multi-task in a high-volume environment with shifting priorities and good leadership.
• Manages change with a positive approach to the challenges of change for self, team and the business. Sees change as an opportunity to
improve performance and add value to the business.

Key stakeholders and relationships

Internal (to AZ or team)
• Development Operations in R&D China:
- Country Study Team
- Global Study Team
- Site Management & Monitoring Team
- Clinical Quality Team
- Clinical Operation Solutions & Excellence Team
- Clinical Operation Engagement & Alliance
Team
• Procurement
External (to AZ)： External Service Providers, e.g. CRO

Date Posted

01-7月-2026

Closing Date

30-7月-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.