Specialist, Global Clinical Solutions

Specialist, Global Clinical Solutions – DPSUAT Team

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

TheGCSSpecialistinDPSUAT (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,Skillsand Experience

Essential

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

• Proven organizational and analytical skills

• Proven ability tomultitasking, time management and havetask orientedperformance

• Previousadministrative training/experience

• Computerproficiency

• Excellent knowledge of spoken and written English

• Strong communicationskills

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 proactivelyidentifyrisks and issues as well aspossible solutions

• GxPtrained

• Some experience in Validation/User Acceptance Testing ofcomputerisedsystems in a regulated environment, preferably thePharmaceuticalindustry, 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 forcomputerisedsystems and infrastructure

• Some experience inIxRS/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 thecountry/ieswhere the role is advertised.