AstraZeneca · 13 hours ago
IRT System Owner (IRT SO), Global Clinical Solutions (GCS)
Durham, NC
Full-time
Hybrid
Senior LevelAstraZeneca is a global biopharmaceutical company dedicated to sustainability and innovation. They are seeking an IRT System Owner to lead the lifecycle management and continuous improvement of clinical systems, ensuring compliance with industry standards and optimal delivery of clinical studies.
BiopharmaBiotechnologyHealth CareMedicalPharmaceuticalPrecision Medicine
Responsibilities
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
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
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
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 critical issue routes and governance bodies to gain traction and deliver rapid solutions
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
Qualification
Required
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
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
Bachelor of Science (BSc) in a suitable field or equivalent experience
Preferred
Understanding of IT infrastructure
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
Extensive 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
Company
AstraZeneca
AstraZeneca is a pharmaceutical company that discovers, develops, manufactures, and markets prescription medicines. It is a sub-organization of Investor.
Founded in 1999
10001+ employees
H1B Sponsorship
AstraZeneca has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2021 (2)
2020 (11)
Funding
Current Stage
Public CompanyTotal Funding
$5.26B2024-07-30Post Ipo Debt· $1.51B
2023-02-28Post Ipo Debt· $2.25B
2023-02-24Post Ipo Debt· $1.5B
Leadership Team
Pascal Soriot
Executive Director and Chief Executive Officer
Aradhana Sarin
Group CFO and Executive Director
Recent News
Essential Business
2026-01-24
2026-01-23
Company data provided by crunchbase