Specialist, Global Clinical Solutions

Specialist, Global Clinical Solutions – DPS UAT Team 

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 Specialist in DPS UAT (User Acceptance Testing) team is expected to be able to take the following roles within the team: 

- 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  

- Vendor Representatives (Project Managers) to set testing pre-requisites and work on testing issues 

Education, Qualifications, Skills and Experience 

Essential 

• Bachelor’s degree or other equal education that supports Skills and Capabilities of the position and ensures successful conduct of accountabilities/responsibilities and appropriate interactions with internal/external customers  

• Proven organizational and analytical skills 

• Proven ability to multitasking, time management and have task oriented performance 

• Previous administrative training/experience 

• Computer proficiency 

• Excellent knowledge of spoken and written English 

• Strong communication skills 

Desirable 

• University degree in biological science or health care related field 

• A good understanding of the clinical study process  

• Programming experience or programming aptitude 

• 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. 

• Shown willingness and ability to train others on study support processes and procedures 

• Demonstrate the ability to proactively identify risks and issues as well as possible solutions 

• GxP trained 

• 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 IxRS/eCOA/ePRO/Spirometry/ECG solutions delivery 

AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.