New
Associate Director, System Owner
Associate Director, System Owner
Requirements
Bachelor of Science (BSc) in a life science or computer science, or equivalent experience
Deep understanding of the drug development process, including clinical development
High level of business process, technology and Clinical Study information knowledge
Extensive experience working with computerized systems in a regulated environment (e.g. GxP).
Experience working successfully and collaboratively with external partners delivering mutual benefit
Proven ability to deliver to time, cost and quality
Demonstrated excellent written and verbal communication skills.
Original Advert
Introduction to role:
Global Clinical Solutions (GCS)drives the delivery of Technology and associated processes for theBioPharmaceuticalsR&D organisation, owning and providing industry leading technology and services on behalf ofClinicalOperations and its internal and external Partnerships.
System Owneris a member of Global Clinical Solutions Technologies (GCS Tech) department and is end-to-end accountable for the leadership, lifecyclemanagementand continuous improvement of ClinicalSystems: Clinical Planning in Planisware and Site Feasibility Assessment, anext generation, AI-driven solution. Works closely with vendors, R&D IT (Information Technology), Functional Process Owners, Business Process Management Office (BPMO), internal and externalcustomersand stakeholders to ensure customer needs are met and to enableoptimalend-to-end delivery of clinical studies.
The System Owneris responsible forthe identification,definitionand delivery of improvements in end-to-end clinical study delivery, utilisingtoolsand techniques to achieve continuous improvement and value creation (i.e. Lean Six Sigma). Ensures that the System meets ICH/GxPrequirements and aligns with industry direction, standards, and best practices.
The System Ownerrepresentsthe business interests in strategy discussions andprovidesstrategic advice to the Governance team in securing long-term business success of their assigned systems. Reviews and approves identified system risks and mitigations. Controls and prioritizes all business requests, such as those for feature enhancements, ensuring prioritization so resources (staff, vendor budget) are spent on value-add activities. Accountable for communication to key stakeholders and the businessregardingthe system (major incidents, new releases, etc.).
Accountabilities:
Design, development, implementation, maintenance, continuousimprovementand ongoing customer support for theallocatedsystems
Accountable for lifecycle management of all procedural or system documents within theallocatedarea, and for ensuring compliance with applicable industry regulations and AstraZeneca Global and Local Policies
Plans and prioritizes product feature backlog and development for the product
Defines system vision,road-mapand growth opportunities
Researches and analyses the business context, the users, and the roadmap for the assigned system
Responsible to partner with and for providing leadership to service delivery teams within the given area.
Engage and influence internal and external key stakeholders to drive the strategy,developmentand continuous improvement within the given area.
Ensure customer requirements are understood, critically evaluated,prioritisedand addressed within the given area.
Member of Operational Governance Teams relating to the given area
Responsible for monitoring performance of the assignedsystem. Define,trackandmonitorkey performance indicators and informimprovement plans.
Support audit and regulatory inspection planning,preparationand conduct.
Understands the processes,technologyand services the study team relies on, their needs and pain points. Uses this knowledge to supply advice and guidance, removes barriers, suppliessolutionsand finds opportunities for improvement.
Supplies guidance andexpertisein the planning and delivery of system validation activities (core system and study specific validation), including production and archiving of all computer system validation documentation.
Essential Skills/Experience:
Bachelor of Science (BSc) in alife science orcomputer science,or equivalent experience
Deep understanding of thedrug developmentprocess, including clinical development
Highlevelof business process,technologyand Clinical Study information knowledge
Extensive experienceworking withcomputerizedsystemsina regulated environment(e.g.GxP).
Experience working successfully and collaboratively with external partners delivering mutual benefit
Proven abilityto deliver to time,costand quality
Demonstrated excellent written and verbal communicationskills.
Desirable Skills/Experience:
Experience intech industry
Experience of using standard process improvement methodologies (e.g. Lean Six Sigma)
Comprehensive knowledge of ICH/GCP
Recognised AGILE certification (e.g.SAFe)
Experience of Quality Systems and Quality Management
Project Management certification
Project Management softwareexperience(e.g. Jira) familiarity
Service Management experience
Experience working with Artificial Intelligenceimplementation
When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.
Are you ready to make a difference?
Date Posted
26-may-2026Closing Date
09-jun-2026AstraZeneca 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.
Application managed by AstraZeneca