Location: Warsaw or Cracow

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

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

The GCS Associate - Data Solutions is expected to be able to take the following roles within the team:

• Data transfer lead – is responsible for data transfer activities for assigned studies making sure to deliver clinical data for Global Study teams in accordance to process and systems requirements:
    - providing constant support for data transfer activities according to agreed timelines and requirements
  - subject matter expert for clinical data transfers to AstraZeneca data repositories
  - supports service of clinical data transfers for assigned studies (all study phases) ensuring quality and following GxP requirements
• Activity team member– is responsible for actively support Activity Leads in DataSolutions expert teams responsible for main service areas:
• Support team activities with business as usual team tasks according to agreed timelines and requirements
• Support activity processes and documentation updates
• Improvement projects support– implementation activities and documentation support (User Acceptance Testing, creation User Requirement Specification, etc.)
• Project team member – actively participating in assigned project tasks. Owning and keeping timelines of parts of the project

Essential

• University degree in related discipline, preferable technology relevant discipline, life science or health care related field or equivalent experience in the aforementioned disciplines
• 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
• Proven ability to multitasking, time management and have task-oriented performance
• Computer proficiency
• Excellent knowledge of spoken and written English
• Strong business communication and presentation skills
• Shown willingness and ability to train others on study support processes and procedures
• Exhibit of AZ Values and Behaviours

Desirable

• Experience in Drug Development within a pharmaceutical or clinical background
• Experience in the development and management of Business Process to deliver business performance
• A good understanding of the clinical study process
• Programming experience or programming aptitude
• Knowledge of pharmaceutical drug development and clinical study processes and associated government regulations, ICH GCP.
• Demonstrates the ability to proactively identify risks and issues as well as possible solutions
• Experience of utilizing standard process improvement methodologies
• Some experience in Validation/User Acceptance Testing of computerized systems in a regulated environment, preferably the Pharmaceutical industry
• GxP trained
• Previous administrative training/experience

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.