Global Clinical Solutions (GCS) 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 Development Operations and its internal and external Partnerships.  

The Project & Change Specialist is a member of Document and Unified Clinical Systems (DUCS) team within Global Clinical Solutions, and is responsible for the coordination/leading the activities ensuring lifecycle management and business continuity for Clinical Operations processes and tools within the DUCS area.

The role will proactively ensure adequate change management activities are included and executed in the initiatives he/she is involved in.

Individuals in this job may be assigned one or more roles relating to the development and maintenance of Global Clinical Solutions processes, systems and services owned by Development Operations.

All Projects & Change Specialists will lead and project manage improvement projects as needed, and will contribute to functional and regional initiatives. 

Typical Accountabilities

• Document and Unified Clinical Systems (DUCS) Projects & Change:

For specific Projects related to DUCS area: lead/coordinate/ deliverables according to the scope of the project :

• Acts as User Acceptance Test Leader for projects or sub-projects
• Provides business insight and expertise to the project teams to develop understanding of change impacts, inputs into the change plan and drive implementation of the change plan across Development Operations Functions in AZ R&D
• Participate in migration/transition projects where documents and information are to be migrated to Veeva-Clinical Vault system from external Pharma Companies or external vendors
• Participates in cross-functional Projects teams with responsibility to deliver specific activities
• Ensures the effective resolution of process, technology and service risks and issues. 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 Enablement personnel to drive continuous improvement.
• Operational Activities

As the member of a specific activity team within Document and Unified Clinical Systems team:

• Coordinates and delivers GCS services across drug projects,
• Coordinates life cycle management and business continuity for Development Operations processes, systems/tools, standards, procedural documentation and training materials,
• Provides expert support to user communities including
  • conducting relevant process/system/tool trainings
  • facilitating knowledge sharing
  • establishing of best practice
  • ensuring communication within Development Operations
• Conducts critical analyses of Development Operations processes and tools to define business usage and identify opportunities to improve efficiency/effectiveness of systems/methods/processes; Define and develop User Requirement Specifications and User Acceptance Tests
• Maintains an awareness of the trends/changes in the external clinical process and technology environment to identify opportunities for improvement; participate in the evaluation and assessment of new technologies
• Contributes to and/or develops business cases for continuous improvement project
• Participates in change initiatives relating to Development Operations.
• 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.

Education, Qualifications, Skills and Experience

Essential

• University degree in related discipline, preferably in biological science or healthcare-related fields, such as medicine, nursing or sanitary engineering, or equivalent experience in the aforementioned disciplines
• At least 2 year experience in Drug Development within a pharmaceutical or clinical background
• Understanding of the clinical study and drug development process and ICH GCP guidelines in relation to study delivery operational activities
• Ability to work collaboratively; proven organizational and analytical skills, and proven skills to deliver to time, cost and quality
• Computer proficiency
• Excellent knowledge of spoken and written English
• Strong business communication and presentation skills
• Ability to transfer knowledge efficiently (mentorship/trainings)
• Exhibit of AZ Values and Behaviours

Desirable

• Expert reputation within AZ business area
• Experience of projects utilising Agile Process and principles
• 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
• Some 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
• Some experience of Quality Systems and Quality Management, including process definition and process improvement, ideally within an Information Systems environment

Key Relationships to reach solutions

Internal (to AZ or team)

• Senior Management
• Development Operations personnel
• Other AstraZeneca employees

External (to AZ)

• External Service Providers

AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.

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.