System Owner In Medical And Safety Review Domain - Associate Director, 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.
The System Owner (SO) for Medical and Safety review applications is a member of Global Clinical Solutions, Business Technology Solutions (BTS) 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 data review / visualization systems in the Clinical space. The candidate should have knowledge of Clinical Development lifecycle and preferably Medical and Safety monitoring systems and relevant technology competency.
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. You will be 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.
Typical Accountabilities

• Actively look for and promote creative and innovative ideas to drive performance and bring innovative solutions to customers.
• Engage and influence internal and external key stakeholders to drive the strategy, development and continuous improvement within the given area.
• Shares lessons learned and best practice recommendations with the Study Team and with GCS personnel to drive continuous improvement.
• Customer Service and Support: As the primary point of contact for Development Operations GCS processes, technology and services within a Study Team:
• 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
• Defines system vision, road-map and growth opportunities
• 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
• 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
• 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.
• Accountable for the design, development, implementation, maintenance, continuous improvement and ongoing customer support for the allocated 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.
• System Ownership: As the allocated owner for a specific clinical computerized system:
• 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.
• Researches and analyses the business context, the users, and the roadmap for the assigned system
• 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.
• Responsible to partner with and for providing leadership to service delivery teams within the given area.
• Member of Operational Governance Teams relating to the given area
• Computer System Validation Oversight:
• Accountable for the effective and timely communication of information, and for the development and delivery of high-quality training materials for the allocated area
• Plans and prioritizes product feature backlog and development for the product

Essential

• Experience in working successfully and collaboratively with external partners (vendors) delivering mutual benefit
• 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
• Experience in Drug Development within a pharmaceutical or clinical background
• Ability to work collaboratively, motivate and empower others to carry out individual, team, and organizational objectives.
• Bachelor of Science (BSc) in a suitable discipline or equivalent experience
• Demonstrated project management skills and proven skills to deliver to time, cost, and quality
• High-level of business process, technology and Clinical Study information knowledge
• Demonstrated excellent written and verbal communication and influencing skills, negotiation, collaboration, problem solving, presentation, knowledge transfer (mentoring), conflict management and interpersonal skills.

Desirable

• Service Management experience. Incident, Problem, Change and Release Management (ITIL)
• Comprehensive knowledge of ICH/GCP
• Project Management certification
• Expert reputation within the business and industry
• Recognised AGILE certification (e.g. SAFe)
• Experience in the development and management of Business Process to deliver business performance
• Experience of using standard process improvement methodologies to find root causes of process issues and find areas of process improvement.
• Extensive experience of Quality Systems and Quality Management, including process definition and process improvement, ideally within an Information Systems environment