Job Description
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, , 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 a...