System Owner - Clinical Systems

Job Description

Global Clinical Solutions (GCS) drives the delivery of Technology and Business Process Excellence for the BioPharmaceuticals R&D organization, owning and providing industry leading process, technology and services on behalf of Development Operations and its internal and external Partnerships.

System Owner (Enablement Manager) is a member of Global Clinical Solutions, Business Technology Solutions department and is end-to-end responsible for the leadership, lifecycle management and continuous improvement of Biometrics systems as assigned. This system owner role is planned to cover multiple systems in the Clinical space.

What You’ll do

The System Owner works closely with vendor(s) if applicable, R&D IT, Business Process Owners, 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, utilizing tools and techniques to achieve continuous improvement and value creation (i.e. Lean Six Sigma).

The BSO ensures that the system meets ICH/GxP requirements and aligns with industry direction, standards, and best practices.

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 limited resources (both staff, vendor limitations, budget) are spent on high-value requests. Responsible of communications for key stakeholders and the business during “Major” system incidents.

Individuals in this job may be assigned one or more roles relating to the development and maintenance of GCS processes, systems and services owned by BioPharmaceuticals R&D Development Operations.

All System Owners will lead and manage improvement projects as needed, and will contribute to functional and regional initiatives.

1) Process, System or Service Ownership:
As the allocated owner for a specific Development Operations process, system or service Enablement Manager is:

• Responsible for the design, development, implementation, maintenance, continuous improvement and ongoing customer support for the allocated area
• Responsible 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
• Responsible for the effective and timely communication of information, and for the development and delivery of high quality training materials for the allocated area
• Responsible for providing training, advice and end user support for the allocated process, system or service
• Responsible for the leadership of service delivery teams within the allocated area
• Engage and influence internal and external key stakeholders to drive the strategy, development and continuous improvement within the allocated area
• Ensure customer requirements are understood, critically evaluated, prioritized and addressed within the allocated area. Work with GCS Leadership and Clinical Development Leadership to prioritize the needs and resources required to deliver these requirements, and provide feedback and clear rationale for any areas that will not be addressed
• Member of Executive Steering Committees and Governance Teams relating to the allocated area
• Responsible for monitoring performance of the allocated process, system or service. Define, track and monitor key performance indicators and use these data to inform selection of process 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 Enablement Leadership as required
• Actively seek and promote creative and innovative ideas to drive performance and bring new solutions to customers.
  

2) 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 provide advice and guidance, removes barriers, provides solutions and identifies 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:

Provides 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 for the role:

• Bachelor’s of Science in an appropriate 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 computerized 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 etc.) requirements for computerized 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 accomplish 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.

Desirables for the role:

• Expert reputation within the business and industry
• Experience of utilizing standard process improvement methodologies (e.g. Lean Six Sigma) to identify root causes of process issues and identify areas of process improvement
• Comprehensive knowledge of ICH/GCP
• Extensive experience of Quality Systems and Quality Management, including process definition and process improvement, ideally within an Information Systems environment
• ITIL certification
• Project Management certification
• Service Management experience. Incident, Problem, Change and Release Management