Associate Director, Global Clinical Solutions

AstraZeneca•Durham, NC

50d•Hybrid

About The Position

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 Clinical Operations and its internal and external Partnerships. Associate Director, Global Clinical Solutions (Clinical System Access Management System Owner) is a member of Global Clinical Solutions Technologies (GCS Tech) department and is end-to-end accountable for the leadership, lifecycle management and continuous improvement of Clinical System Access Management System. The System Owner works closely with vendors, 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. System Owner is 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). System Owner 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 systems. Reviews and approves identified system risks and mitigations. Controls and prioritizes all business requests, such as those for feature enhancements, ensuring prioritization 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.

Requirements

Bachelor of Science (BSc) in a life science or computer science, or equivalent field
5 years of relevant experience
Deep understanding of the drug development process, including clinical development
High level of business process, technology and Clinical Study information knowledge
Extensive experience working with computerized systems in a regulated environment (e.g. GxP).
Experience working successfully and collaboratively with external partners delivering mutual benefit
Proven ability to deliver to time, cost and quality
Demonstrated excellent written and verbal communication skills

Nice To Haves

Experience in tech industry
Experience of using standard process improvement methodologies (e.g. Lean Six Sigma)
Comprehensive knowledge of ICH/GCP
Recognised AGILE certification (e.g. SAFe)
Experience of Quality Systems and Quality Management
Project Management certification
Project Management software experience (e.g. Jira) familiarity
Service Management experience
Experience working with Artificial Intelligence implementation

Responsibilities

Accountable for the design, development, implementation, maintenance, continuous improvement and ongoing customer support for the allocated systems
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
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.
Member of Operational Governance Teams relating to the given area
Responsible for monitoring performance of the assigned system. Define, track and monitor key performance indicators and inform improvement plans.
Support audit and regulatory inspection planning, preparation and conduct.
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.
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.