System Owner

**The Role **GCS Business Technology owns and provides industry leading process, technology and

services on behalf of Biopharma Clinical Operations and its internal and external Partnerships.

The EDC maintenance team member is a key member of GCS, Business Technology, and is responsible for the leadership, lifecycle management and continuous improvement of a specific Biopharma Clinical Operations process, system or service. Working collaboratively with 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 play a vital role in 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 such as Lean Six Sigma.

**Main responsibilities**
- Design, development, implementation, maintenance, continuous improvement and ongoing customer support
- Lifecycle management of all system documents, and for ensuring compliance with applicable industry regulations and AstraZeneca Global and Local Policies
- Effective and timely communication of information, and for the provision of high quality training materials
- Responsible for providing training, advice and end user support
- Leadership of service delivery teams
- Engage and influence internal and external key partners to drive the strategy, development and continuous improvement
- Ensure customer requirements are understood, critically evaluated, prioritised and addressed. Work with GCS Leadership and Biopharma Clinical Operations Leadership to prioritise 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
- Responsible for monitoring performance. Define, track and monitor key performance indicators and use these data to inform selection of process improvements, working in collaboration with GCS Leadership
- Support audit and regulatory inspection planning, preparation and conduct. Deliver
- Corrective and Preventive Actions to time and quality, and act on data or trends identified through the Quality & Risk Management process. Advance risks and issues to GCS
- Leadership as required
- Actively seek and promote creative and innovative ideas to drive performance and bring new solutions to customers.

**Requirements**:
**Essential**
- Extensive knowledge of Drug Development within a pharmaceutical or clinical background
- High level of business process, technology and Clinical Study information experience
- Demonstrated project management skills to deliver to time, cost and quality
- Ability to collaborate with, and motivate and empower others to accomplish individual, team and organisational objectives. Also have experience in working successfully with external partners delivering mutual benefit
- Demonstrated excellent written, verbal and influencing skills. Also negotiation, collaboration, problem solving, presentation, knowledge transfer (mentoring), conflict management and interpersonal skills.
- Experience in Medidata Rave including iMedidata user and site administration, report administration, core configuration, study build and edit check programming.

**Desirable**
- Expert reputation within the business and industry
- Experience of utilising standard process improvement methodologies (e.g. Lean Six Sigma) to identify root causes of process issues and identify areas of process improvement
- Experience in the development and management of Business Processes to deliver business performance
- Comprehensive knowledge of ICH/GCP
- 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 etc.) requirements for computerised systems and infrastructure
- Extensive experience of Quality Systems and Quality Management, including process definition and process improvement, ideally within an Information Systems environment.
- Ability to set and manage priorities, resources, performance targets and project initiatives in a regional environment.
- Medidata Study Builder certification
- Experience in other EDC systems (e.g Veeva, Bioclinica)
- Experience in other Medidata products including Rave EDC, Site Cloud, Medidata Coder, RSG