IRT System Owner, Global Clinical Solutions

IRT System Owner(IRT SO), Global Clinical Solutions(GCS)

Global Clinical Solutions (GCS) drives the delivery of Technology and associated processes for the BioPharmaceuticals R&D organisation, owning and providing industry leading technology and services on behalf of Development Operations and its internal and external Partnerships.  

IRTSystem Owner(IRT SO) is a member of Global Clinical Solutions Technologies (GCS Tech) department and is end-to-end accountable for the leadership, lifecycle management and continuous improvement of Clinical systems as assigned. The System Owner can cover one or more systems in the Clinical space.

The System Owner works closely with vendor(s) if applicable, R&D IT (Information Technology), Functional Process Owners, Business Process Management Office (BPMO), 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, utilising tools and techniques to achieve continuous improvement and value creation (i.e. Lean Six Sigma).

The SO ensures that the System meets ICH/GxP requirements and aligns with industry direction, standards, and best practices. 

The System Owner represents the business interests in strategy discussions and provides strategic advice to the Governance team in securing long-term business success of their assigned system(s). Reviews and approves (if acceptable) identified system risks and mitigations. Controls and prioritizes all business requests, such as those for feature enhancements, ensuring prioritization takes place so resources (staff, vendor budget) are spent on value-add activities. Accountable for communication to key stakeholders and the business regarding the system (major incidents, new releases, etc.)All System Owners will lead and manage improvement projects as needed, and will contribute to functional, regional and or global initiatives.

TypicalAccountabilities

• Accountable for the design, development, implementation, maintenance, continuous improvement and ongoing customer support for the allocated area

• Accountable for lifecycle management of all procedural or system documents within the allocated area, 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-map and growth opportunities

• Researches and analyses the business context, the users, and the roadmap for the assigned system

• Accountable for the effective and timely communication of information, and for the development and delivery of high-quality training materials for the allocated area

• 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, development and continuous improvement within the given area.

• Ensure customer requirements are understood, critically evaluated, prioritised and addressed within the given area. Work with GCS Leadership and Development Operations Leadership to prioritise the needs and resources needed to deliver these requirements, and supply feedback and clear rationale for any areas that will not be addressed.

• Member of Operational Governance Teams relating to the given area

• Responsible for monitoring performance of the assign system. Define, track and monitor key performance indicators and use these data to inform choice of process and system improvements and input to cross-functional improvements, working in collaboration with GCS Leadership

• Support audit and regulatory inspection planning, preparation and conduct. Responsible for the delivery of Corrective and Preventive Actions to time and quality, and for acting on data or trends identified through the Quality & Risk Management process. Escalate risks and issues to GCS Leadership as needed. 

• Actively look for and promote creative and innovative ideas to drive performance and bring innovative solutions to customers.

• Understands the processes, technology and services the study team relies on, their needs and pain points. Uses this knowledge to supply advice and guidance, removes barriers, supplies solutions and finds opportunities for improvement.

• Ensures the effective resolution of process, technology and service risks and issues that impede the Study Teams progress and effective delivery. Identifies and engages with the right process, technology and 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.

• Supplies guidance and expertise in the planning and delivery of system validation activities (core system and study specific validation), 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