Functional Process Owner, Clinical System Access Management
Global Clinical Solutions (GCS) drives the delivery oftechnology and associated processes for theBioPharmaceuticalsR&D organisation, owning and providing industry leading technology and services on behalf ofClinicalOperations and its internal and externalpartnerships.
TheFunctional Process Owner (FPO)of Clinical System Access Management (CSAM) processis a member of Global Clinical SolutionsTechnologiesdepartment and isend-to-end responsible for the leadership, lifecycle management and continuous improvement of assigned system processes,guidelinesand user manuals.
The FPO works closely with System Owner, vendor(s) if applicable, Business Process Management Office (BPMO), R&D IT (Information Technology), internal and externalcustomersand stakeholders to ensure customer needs are met and to enableoptimalend-to-end delivery of clinical studies. Responsible for the 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).
The FPO ensures that the defined system processes,guidelinesand user manuals meets AZ requirements, standards, bestpracticesand they are in line with SOPs and other processes. The FPO collaborates closely with BPM Lead to confirm alignment of managed processes with overarching higher-level processes (e.g. SOPs).
The FPOrepresentsthe business interests in strategy discussions andprovidesstrategic advice to the Governance team in securing long-term business success in their assigned areas. Reviews and approves (if acceptable)identifiedsystem process risks and mitigations.
All Functional Process Ownerswill lead and manage improvement projects asneeded andwill contribute to functional and regional initiatives.
Typical Accountabilities
1.) System Process Ownership:
As theallocatedowner for a specific set ofClinicalOperations system processes, Functional Process Owneris responsible for:
The lifecycle management - design, development, implementation, maintenance, continuous improvement - of the system processes for theallocatedarea
The development and delivery ofhigh-qualityguidelines, user manuals, training materials, relevanttemplatesand toolkit documents
Providing advice, training and end user support for the system processes and other system supporting documents
Defining,trackingandmonitoringkey performance indicators of theallocatedsystem process, and using these data to informselectionof system process improvements and input to cross-functional improvements.
The delivery of Corrective and Preventive Actions (CAPA) to time and quality, and for acting on data or trendsidentifiedthrough the Quality & Risk Management process.
Escalating risks and issues asrequired
The FPO will:
Ensure customer requirements are understood, critically evaluated,prioritisedand addressed within theallocatedsystem process area and provide feedback and clear rationale for any areas that will not be addressed
Engage and influence internal and external key stakeholders to drive the system processes strategy,developmentand continuous improvement within theallocatedarea
Liaise with relevant Process Owners, Business Process ManagementOfficeand Governance Team representatives to ensure alignment and cross-functional approach
Liaise with relevant System Owner(s) to ensure that system processes and procedures are aligned
Communicate and provide input to Business Process Management Office and Process Owners for evaluation of new SOPs and regulations related to the process.
Be a member of Governance Teams relating to theallocatedarea
Support audit and regulatory inspection planning,preparationand conduct.
Activelyseekand promote creative and innovative ideas to drive performance and bringnew solutionsto customers.
2) Customer Service and Support:
As the primary point of contact forGlobal Clinical Solutionsprocesses:
Understands the system processes,technologyand services the study team relies on, their needs and pain points. Uses this knowledge to provide advice and guidance, removes barriers, providessolutionsandidentifiesopportunities for improvement
Ensures the effective resolution of system process risks and issues that impede the Study Teams progress and effective delivery.Identifiesand engages with the right process,technologyand service experts, and expertly utilises escalation routes and governance bodies to gain traction and deliver rapid solutions
Shares lessons learned and best practice recommendations with the Study Team and with GCS personnel to drive continuous improvement.
Essential
- Bachelor of Science (BSc) inan appropriate disciplineor equivalent experience
- 5+ years experience inDrug Developmentwithin a pharmaceutical or clinical background
- Strong business process,technologyand ClinicalStudy information knowledge
- Strong operational knowledge of system processes in the clinical trial setting
- Demonstrated project management skills and proven skills to deliver to time,costand quality
- Ability to work collaboratively, motivate and empower others toaccomplishindividual, team and organizational objectives
- Vendor Management - experience in working successfully and collaboratively with external partners delivering mutual benefit
- Demonstrated excellent written and verbal communication and influencing skills, negotiation, collaboration, problem solving, presentation, knowledge transfer (mentoring), conflictmanagementand interpersonal skills.
Desirable
- Expert reputation within the business and industry
- Experience ofutilizingstandard process improvement methodologies (e.g., Lean Six Sigma) toidentifyroot causes of process issues andidentifyareas of process improvement
- Experience in the development and management of Business Processes to deliver business performance
- Comprehensive knowledge of ICH/GCP
- Extensive experience in Validation of computerised systems in a regulated environment, preferably thePharmaceuticalindustry, including familiarity with documentation such as Validation Plans, Reports, Test scripts etc. and knowledge of regulatory (GxP, SOX, etc.) requirements for computerised systems and infrastructure
- Extensive experience of Quality Systems and Quality Management, including process definition and process improvement, ideally within an Information Systems environment.
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.
Why AstraZeneca?
At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth and development. We’re on an exciting journey to pioneer the future of healthcare.
So, what’s next!
Are you ready to bring new ideas and fresh thinking to the table? Brilliant! We have one seat available and we hope it’s yours.
Date Posted
17-Dec-2025Closing Date
04-Jan-2026Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In 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.
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