The Development Operations organisation brings together all the skills groups to drive critical operational activities for early and late stage medicines development.  We have deep and specialist expertise in study and site management, data management, technical systems and processes, and in working with CROs and partner organisations to ensure the fast, efficient, ethical and quality delivery of our clinical trials in countries around the world.

Global Clinical Solutions drives the delivery of Business Process Excellence and Technology for the Development Operations organisation, owning and providing industry leading process, technology and services on behalf of Clinical Operations and its internal and external Partnerships.  

The GCS Manager is a member of Global Clinical Solutions, and is responsible for the leadership, lifecycle management and continuous improvement of a specific Development 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. The GCS Manager 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 such as Lean Six Sigma.

Individuals in this job are assigned one or more roles relating to the development and maintenance of GCS processes, systems and services owned by Development Operations.

All GCS Managers will lead and project manage improvement projects as needed, and will contribute to functional and regional initiatives. 

Typical Accountabilities

Process, System or Service Ownership:
As the allocated owner for a specific process, system or service the GCS 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, prioritised and addressed within the allocated area. Work with Enablement Leadership and 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 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 Enablement 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.
• Proactively  uses change management plans and methodology to seek opportunities to drive positive change and remove barriers within and outside the team.

Local Line Management:

• Provides local management and leadership to fulfil management accountabilities and local employment law requirements
• Attracts, develop and retain top talent and actively work to promote team building and morale within the department
• Provides direction, real time situational mentoring, career development guidance, and coaching as appropriate
• Provides performance management, performance assessment and reward and recognition proposals for direct reports.

Essential

• 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
• 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 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
• 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
• Experience in the development and management of Business Process to deliver business performance
• 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
• Experience of Line management and in driving performance on a local basis. Ability to set and manage priorities, resources, performance targets and project initiatives in a regional environment.

Date Posted

Closing Date

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.