Medical Imaging System Owner

AstraZeneca•Durham, NC

About The Position

Typical Accountabilities: 1) 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, prioritised and addressed within the given area. Work with GCS Leadership and Clinical 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. 2) Customer Service and Support: As the primary point of contact for Clinical 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. 3) 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.

Requirements

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.

Nice To Haves

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

Responsibilities

System Ownership: Accountable for design, development, implementation, maintenance, continuous improvement, and customer support.
Lifecycle management of procedural/system documents and compliance with regulations and policies.
Plan and prioritize product feature backlog and development.
Define system vision, road-map, and growth opportunities.
Research and analyze business context, users, and system roadmap.
Communicate information effectively and develop high-quality training materials.
Partner with and provide leadership to service delivery teams.
Engage and influence stakeholders to drive strategy and continuous improvement.
Ensure customer requirements are understood, prioritized, and addressed.
Work with leadership to prioritize needs and resources.
Participate in Operational Governance Teams.
Monitor system performance and define/track key performance indicators.
Support audit and regulatory inspection planning and conduct.
Deliver Corrective and Preventive Actions and act on data/trends.
Escalate risks and issues to leadership.
Promote creative and innovative ideas.
Customer Service and Support: Act as the primary point of contact for Clinical Operations GCS processes, technology, and services.
Understand study team needs and provide advice, guidance, and solutions.
Resolve process, technology, and service risks and issues.
Engage with experts and utilize escalation routes.
Share lessons learned and best practice recommendations.
Computer System Validation Oversight: Provide guidance and expertise in system validation activities.