Manager, Global Clinical Solutions - UAT Team

Job Title:

Manager, Global Clinical Solutions (UAT -

User Acceptance Testing

)

Location

: Warsaw, Poland

Work model

: Hybrid (3 days per week in office)

About the role

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

GCS Manager

– UAT Team is expected to be able to take the following roles within the team:

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 skills/experience

:

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)

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