System Owner - Clinical Control Tower (Associate Director, Global Clinical Solutions)

Location:Warsaw
Hybrid model of work(3 days from the office, 2 days from home)

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, Technology 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 systems in the Clinical space.

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. 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

System Ownership

• Vision & Roadmap: Define system vision and roadmap; prioritize backlog and delivery.
• Lifecycle & Compliance: Own end-to-end lifecycle from project to BAU, including documentation, regulatory compliance, and license-to-operate.
• Governance Leadership: Lead and participate in steering committees and operational governance forums; ensure alignment with IT/DevOps and agile ways of working.
• Operational Oversight: Oversee KPIs and risk reviews; coordinate incidents, escalations, and CAB/CCB; manage collaboration with vendors and internal teams.
• User & Business Insight: Understand business context and user needs to inform product decisions.
• Communication & Training: Ensure effective communication and high-quality training materials and delivery.
• Risk, Quality & Audits: Drive audit/inspection readiness and CAPA; escalate risks per Quality & Risk Management processes.
• Continuous Improvement: Promote innovation and share lessons learned and best practices to drive performance.

Customer Service and Support

• Primary Contact: Serve as the primary point of contact for GCS processes, technology, and services within Study Teams; remove barriers, advise, and deliver solutions.
• Issue Resolution & Governance: Secure rapid resolution by engaging the right experts, escalation routes, and governance bodies.
• Stakeholder Engagement: Act as primary contact for business, IT, and vendors; facilitate PI planning and manage cross-team dependencies.

Computer System Validation Oversight

• CSV Oversight: Provide guidance and oversight for system validation (core and study-specific), including production and archiving of all validation documentation.

Essential

• Bachelor of Science (BSc) in 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.
• In-depth knowledge of Agile process and principles
• 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.

Desirable

• Expert reputation within the business and industry
• Comprehensive 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
• Service Management experience. Incident, Problem, Change and Release Management (ITIL) Project Management certification
• Experience in the development and management of Business Process to deliver business performance

Date Posted

11-gru-2025

Closing Date

23-gru-2025

AstraZeneca embraces diversity and equality of opportunity.  We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.  We believe that the more inclusive we are, the better our work will be.  We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.  We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.