Join our Global Clinical Solutions (GCS) team, a driving force behind the delivery of Technology and associated processes for the BioPharmaceuticals R&D organisation. As a System Owner, you will be a key player in the leadership, lifecycle management, and continuous improvement of Clinical systems. This role requires experience in Drug Development lifecycle and Analysis and Reporting processes. You will be responsible for a system in the Clinical A&R and Standards team, ensuring that it meets ICH/GxP requirements and aligns with industry direction, standards, and best practices.
Accountabilities System Ownership:
As the allocated owner for a specific clinical computerized system:
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, prioritized and addressed within the given area. Work with GCS Leadership and Development Operations Leadership to prioritize 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 assigned 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. Customer Service and Support:
As the primary point of contact for Development Operations GCS processes, technology and services within a Study Team:
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. Computer System Validation Oversight: 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. Essential Skills/Experience: Bachelor of Science (BSc) in a suitable discipline or equivalent experience. 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. 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. Experience in working successfully and collaboratively with external partners (vendors) delivering mutual benefit. Demonstrated excellent written and verbal communication and influencing skills, negotiation, collaboration, problem solving, presentation, knowledge transfer (mentoring), conflict management and interpersonal skills. Documentation skills (CRs, plans, reports etc.) in a GxP context. Desirable Skills/Experience: 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). PowerBI reports/dashboards certification and experience. Extensive experience of Quality Systems and Quality Management, including process definition and process improvement, ideally within an Information Systems environment. Project Management certification. Service Management experience. Incident, Problem, Change and Release Management (ITIL). Experience in the development and management of Business Process to deliver business performance. Experience as a test leader for software development of GxP regulated systems. At AstraZeneca, we are committed to making a difference. We have built our business around our passion for science. Now we are fusing data and technology with the latest scientific innovations to achieve the next wave of breakthroughs. We are always listening and learning from people who live with the diseases our medicines treat. It enables us to better understand their needs and, ultimately, diagnose and design the right treatments to impact patients' lives.
Are you ready to join a team that is unlocking the power of what science can do? Are you ready to push the boundaries of science to deliver life-changing medicines? If so, apply today!
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