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 GCS Associate is a member of the Document and Unified Clinical Systems (DUCS) team within Global Clinical Solutions, and is Actively support Development Operations by ensuring the population and availability of complete, high quality data from Clinical Operations processes and systems. Deliver Clinical Operations processes and systems trainings and participate in the coordination of the life cycle management of processes and systems/tools including associated documentation (procedural, system). Deliver global centralized services across drug projects and/or other activities that enable delivery of Development Operations programs to time, cost, and quality across all delivery models.

The role will participate in change management activities 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 GCS processes, systems and services owned by Development Operations.

All GCS Associates will participate in improvement projects as needed, and will contribute to functional and regional

Typical Accountabilities

Operational Activities

As the member of a specific activity team the GCS Associate

• Delivers GCS services across drug projects
• Sets up and maintains systems/tools and data associated with DEVOPS enabling services in partnership with Study Teams and external partners to appropriate standards, completeness, quality and consistency
• Supports life cycle management and business continuity for DEVOPS processes, systems/tools, standards, procedural documentation and training materials,
• Provides support to user communities including
  • conducting relevant process/system/tool trainings
  • facilitating knowledge sharing
  • establishing of best practice
  • ensuring communication within DEVOPS
  • Performing validation and testing of processes and systems
• Performs analyses of GCS processes and tools to define business usage and identify opportunities to improve efficiency/effectiveness of systems/methods/processes; Support in User Requirement Specifications and User Acceptance Tests
• Contributes to business cases for continuous improvement project
• Participates in change initiatives relating to GCS.

Education, Qualifications, Skills and Experience

Essential

• Bachelor’s degree or other equal education that supports Skills and Capabilities of the position and ensures successful conduct of accountabilities/responsibilities and appropriate interactions with internal/external customers
• Proven organizational and analytical skills
• Proven ability to multitasking, time management and have task oriented performance
• Previous administrative training/experience
• Computer proficiency
• Excellent knowledge of spoken and written English
• Strong communication skills
• Exhibit of AZ Values and Behaviors.

Desirable

• University degree in biological science or health care related field
• A good understanding of the clinical study process
• Experience and skills in using and maintaining the Veeva-Clinical-Vault (VCV) tool and processes
• Programming experience or programming aptitude
• Work experience in the pharmaceutical industry or in the environment of clinical study delivery/clinical development processes
• Knowledge of pharmaceutical drug development and clinical study processes and associated government regulations, ICH GCP.
• Shown willingness and ability to train others on study support processes and procedures
• Demonstrate the ability to proactively identify risks and issues as well as possible solutions
• GxP trained

Key Relationships to reach solutions

Internal (to AZ or team)

• Senior Management
• Global Medicines Development personnel
• Other AstraZeneca employees

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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

18-mar-2021

Closing Date

31-mar-2021

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.