Product Owner (IRT Integration), Global Clinical Solutions

Global Clinical Solutions(GCS)

The IRT Integration Product Owneris a member of Global Clinical Solutions, Business Technology Solutions (BTS) department and will support the strategic leadership, lifecycle management and continuous improvement of AstraZeneca Interactive Response Technology (IRT) systems.

The IRT Integration Product Ownerworks closely with vendor(s), R&D IT (Information Technology),Functional Process Owners, System Owners, Business Platform Lead, internal and external customers and stakeholders to ensure customer needs are met and to enable optimal end-to-end delivery of clinical studies. Responsible for the identification, definition and delivery of improvements in end-to-end clinical study delivery, utilisingtools and techniques to achieve continuous improvement and value creation (i.e. Lean Six Sigma).

IRT Integration Product Owner drives the innovation work and manages the development of new integrationsacross IRT clinical platform to enable inbound/outbound IRT data flow and data ingestion to other systems and reporting tools. Provides the ownershipto the data model and ensures it is synchronized with broader clinical ecosystem and global data standards through effective collaboration with other stakeholders e.g. Digital Health, Global Clinical Supply Chain, Statistics etc. 

Drives the implementation of changes and improvements to existing IRT platform components.IRT Integration Product Ownerensures that IRT data integrations are developed and maintained following ICH/GxP requirements, aligns with industry direction, standards, and best practices.

IRT Integration Product Owner controls and prioritizes all business requests, such as those for new use cases and data integration improvements or existing feature enhancements, ensuring prioritization takes place.

TypicalAccountabilities

• Is responsible for leading the delivery of systems integrations implementation and enhancement projects, including and aligned with AstraZeneca technology strategy

• Ensures that IRT data integrations are developed, maintained and shared with customer following ICH/GxP regulations, industry direction, standards, and best practices

• As a member of IRT Platform Team leads and supports other IRT system and process improvement projects

• Actively looks for and promotes creative and innovative ideas to drive performance and bring innovative solutions to customers

• Plans and prioritizes product feature backlog and development for the product

• Ensures customer requirements are understood, critically evaluated, prioritised and addressed within the allocated area

• Definessystem vision, roadmap and growth opportunities

• Supports audit and regulatory inspection planning, preparation and conduct for the allocated area

• Supplies guidance and expertise in the planning and delivery of system validation activities within allocated area, including production and archiving of all computer system validation documentation

Education, Qualifications, Skills and Experience 

Essential

• Deep understanding of the clinical development business processes, technology (especially IRT), clinical trial information management, regulations and guidelines impacting the drug development process

• Extensive experience in Drug Development within a pharmaceutical or clinical background

• High-level of business process, technology and Clinical Study information knowledge

• Extensive experience in Validation of computerised systems in a regulated environment, preferably the Pharmaceutical industry, including familiarity with documentation such as Validation Plans, Reports, Test scripts etc. and knowledge of regulatory (GxP, SOX (Sarbanes Oxley) etc.) requirements for computerised systems and infrastructure

• Vendor Management - experience in working successfully and collaboratively with external partners delivering mutual benefit

• Demonstrated project management skills and proven skills to deliver to time, cost and quality 

• Ability to work collaboratively, motivate and empower others to carry out individual, team and organizational objectives.

• Demonstrated excellent written and verbal communication and influencing skills, negotiation, collaboration, problem solving, presentation, knowledge transfer (mentoring), conflict management and interpersonal skills.

• Bachelor of Science (BSc) in a suitable discipline or equivalent experience

Desirable

• Understanding  of IT infrasturcture

• Experience in IT industry

• Expert reputation within the business and industry

• Experience of using standard process improvement methodologies (e.g. Lean Six Sigma) to find root causes of process issues and find areas of process improvement.

• Comprehensive knowledge of ICH/GCP

• Recognised AGILE certification (e.g. SAFe)

• Extensive experience of Quality Systems and Quality Management, including process definition and process improvement, ideally within an Information Systems environment

• Project Management certification and Project Management software (e.g. Jira) familiarity

• Service Management experience. Incident, Problem, Change and Release Management (ITIL)

• Experience in the development and management of Business Process to deliver business performance