Manager, Global Clinical Solutions - UAT Team (secondment)

Job Title: Manager, Global Clinical Solutions (UAT - User Acceptance Testing)

Location: Warsaw, Poland
Work model: Hybrid (3 days per week in office)
 

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

The Test Lead in UAT Team (testing of IRT/RTSM solutions) is expected to be able to take the following roles within the team in line with their growing expertise:

• Tester – responsible for Test Scripts execution (during onboarding phase)
• 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.
• Quality Lead – overall accountability for User Acceptance Testing (process, timelines and quality), review and approve of the documents (typically TL grows into the QL role within 1 year of gaining TL experience)
• undefined

The Test Lead 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
• Project Management and stakeholder management skills Ability to work collaboratively; proven organizational and analytical skills, and proven skills to deliver to time, cost and quality
• Ability to proactively identify risks and issues as well as possible solutions
• Strong time management and prioritisation skills
• Strong business communication and presentation skills
• Ability to transfer knowledge efficiently (mentorship/trainings)
• Excellent knowledge of spoken and written English
• Exhibit of AZ Values and Behaviours
• 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
• Some experience in working with IRT/RTSM solutions

Desirable qualifications:

• Some experience of Quality Systems and Quality Management, including process definition and process improvement, ideally within an Information Systems environment
• 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

What we offer:

Welcome to Warsaw Site, one of over 400 sites here at AstraZeneca, providing a collaborative environment where everyone feels comfortable and able to be themselves is at the core of AstraZeneca’s priorities, it’s important to us that you bring your full self to work every day.

To help you maintain your best self, here’s a sneak peek into some of the things this site provides for you:

• The best team to support you,
• Multisport card,
• Pension plan,
• Life insurance,
• after-work events,
• private medical care
• lunch card,
• bright and spacious environment,
• sustainable office working environment.

Please note that we are working in a hybrid model of 3 days per week from the office in Warsaw

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.