Clinical Operations within Global Medicines Development (GMD) is accountable for the delivery of clinical studies.

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

  

The Global Clinical Solutions Assistant is a member of the Clinical Operations Global Clinical Solutions Team, and is actively support Clinical Operations by ensuring the population and availability of complete, high quality data from Clinical Operations processes and systems. 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 Clinical Development programs to time, cost, and quality across all delivery models.

All Global Clinical Solutions Assistant will participate in improvement projects as needed, and will contribute to functional and regional initiatives. 

Operational Activities

As the member of a specific activity team EA:

• Supports Global Clinical Solutions services across drug projects
• Maintains systems/tools and data associated with Clinical Operations 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 Clinical Operations processes, systems/tools, standards, procedural documentation and training materials
• Provides support to user communities including
  • conducting relevant process/system
  • preparing communication within Clinical Operations
  • taking part in validation and testing of processes and systems
     
• Contributes to business cases for continuous improvement project
• Participates in change initiatives relating to Clinical Operations.
• Supports activities that ensure Clinical Operations compliance
  • uploading of documents to Trial Master File
  • performing Quality Check (reviewing safety documents, resolving issues, preparing QC Certificate and logs for Study Teams)
• Works with teams and colleagues across the organization to support consistent ways of working and adherence to best practice

Essential

• Level of education – undergraduate studies
• Proven organizational and analytical skills.
  Display the ability to follow tasks through to completion and to understand how tasks combine into an efficient workflow
• Demonstrated concern for quality and standards, good team-working i.e. cooperation, willingness to learn from others, sharing relevant information, adaptability, self-control, self-accountability for achieving objectives, applying best practice
• Computer proficiency
• Good time management
• Communicative English skills
• Strong communication skills.
• Exhibit of AZ Values and Behaviors.

Desirable

• Some experience with document management systems eg. Electronic Trial Master File
• An understanding of the clinical study process
• 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.

Date Posted

26-sty-2021

Closing Date

25-sty-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.