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Processes&Enabling Solutions Specialist - IRT Lead or Test Lead (fixed term contract, 12 months)

Location Warsaw, Mazovia, Poland Job ID R-059428 Date posted 08/23/2019

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

The PES Specialist - IRT Lead or Test Lead is expected to be able to take the following roles within the team:

  • IRT Lead – IRT project management, process compliance, system expertise, administration tasks and clinical input to User Requirement Specification
  • Quality Lead – overall accountability for User Acceptance Testing (process, timelines and quality), review and approve of the documents
  • Test Lead – responsible for creating User Acceptance Testing documentation (Test Plan, Test Scripts, Test Report), review of the User Requirement Specification (to understand testing requirements) and tracking testing issues
  • Tester – responsible for Test Scripts execution

The team members will be cooperating with:

  • Global Study Team representatives to clarify user requirements, scope of testing and intended system functionality;
  • Supply Chain Study Managers to receive input to the testing documentation
  • Vendor Representatives (Project Managers) to set testing pre-requisites and work on testing issues

Essential qualifications:

  • 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)
  • Some experience in Validation/User Acceptance Testing of computerised systems in a regulated environment, preferably the Pharmaceutical industry, including familiarity with documentation such as Validation/Test Plans, Reports, Test scripts (including test scripts execution), Functional Risk Assessment etc. and knowledge of regulatory (GxP, SOX etc.) requirements for computerised systems and infrastructure

Desirable qualifications:

  • 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 IRT/eCOA/ePRO/Spirometry/ECG solutions delivery
  • Some experience of Quality Systems and Quality Management, including process definition and process improvement, ideally within an Information Systems environment

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 authorisation and employment eligibility verification requirements.

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Glassdoor logo Rated four stars on Glassdoor

Great culture, great work assignments, supportive management. Rotation opportunity within the company. They value inclusion and diversity.