AstraZeneca
biopharmaceutical
AssociateDirectorClinicalSupplyIRT
“Associate Director Clinical Supply IRT at AstraZeneca. Skills: IRT Standards, IRT studies, process management, cross-functional coordination, vendor/stakeholder management, operational metrics, resource planning, continuous improvement. delivering the GCSC inputs to the onboarding and Continuous Improvement of IRT Standards and studies. Inputting to and completing Technical Standards documentation both standards and studies”
What You'll Achieve.
automated inventory management to maintain the right kits, for the right patients, at the right time, in the right place; directly impacts the speed, quality and cost of AZ’s clinical studies; configuration / validation activities are on the critical path for study start up
Industry & Context.
problem- solving skills; proposing solutions to meet programme needs
minimum of three days per week from the office
What They're Looking For.
Must Have
University degree or equivalent qualification in relevant field, In depth knowledge of R&D Supply Chain and drug development process, Deep knowledge of Clinical Development processes relevant to investigational products, Demonstrated hands‑on experience configuring or operating Interactive Response Technology (IRT) for clinical trials, including translating supply chain designs into IRT specifications and user requirements, Track record of creating, maintaining, and improving SOPs, work instructions, templates, and training materials related to IRT and clinical supply processes, Practical experience with one or more IRT platforms, In depth knowledge of IRT systems and interactions, Proficient IT skills with an ability to understand, adapt and operate in multiple systems, influencing, negotiating and problem- solving skills, including across functional, geographical and cultural boundaries, Awareness and understanding of GMP and GCP, Risk identification and management experience
What You'll Do.
delivering the GCSC inputs to the onboarding and Continuous Improvement of IRT Standards and studies
Inputting to and completing Technical Standards documentation both standards and studies
Completing Risk Assessment both standards and studies
Author/approve test scripts as required – both standards and studies
Develop and deliver training material on standards
Create internal SOP’s to document and define process
Represent Global Clinical Supply Chain in governance interactions
both internal and external
Delivery of training and onboarding support for IRT Specialists
mentoring of new team members
Leading development and process activities within the team and across teams
knowledge sharing activities
Consultancy to internal and external groups for both study solutions and process development
assessing programme strategy
proposing solutions to meet programme needs
Process owner for IRT processes / sub processes
Drives and role models excellence in delivery in IRT Set up and change management and associated values and behaviours
develops excellence in others through their interactions with them
How You'll Work.
Team & Collaboration
cross-functional coordination; governance interactions, both internal and external; within both GCSC and Clinical Operations; across teams; Consultancy to internal and external groups
Communication Scope
influencing; negotiating; information sessions; communication
Process & Methodology
programme strategy
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