System Owner, Associate Director, Global Clinical Solutions
3 weeks ago
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) 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. This SO role will be fairly broad and experience in Drug Development Analysis and Reporting processes will be important as the SO will be responsible for a Clinical system or Systems.
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
1) System Ownership:
As the allocated owner for a specific clinical computerized system:
2) Customer Service and Support:
As the primary point of contact for Development Operations GCS processes, technology and services within a Study Team:
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.Essential
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
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.Date Posted
25-kwi-2024Closing Date
15-maj-2024-
Bangalore, India AstraZeneca Full timeGlobal 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) is a member of Global Clinical Solutions, Business...
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