- Entry level
- No Education
- Salary to negotiate
Enablement Specialist in UAT team
Clinical Operations within Global Medicines Development (GMD) is accountable for the delivery of clinical studies.
Enablement drives the delivery of Business Process Excellence and Technology for the GMD Clinical Operations organisation, owning and providing industry leading process, technology and services on behalf of Clinical Operations and its internal and external Partnerships.
The Enablement Specialistin UAT (User Acceptance Testing) 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 (like Test Plan, Risk Assessment, Tractability Matrix, and 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
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
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
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 IxRS/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 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.
About the company
AstraZeneca is a global, science-led biopharmaceutical company that spans the discovery, development, manufacturing, distribution and worldwide commercialisation of primary care and speciality care medicines.
We believe the best way we can help patients is to focus on breakthrough science in order to uncover disease mechanisms and develop novel, targeted therapies that interact with them. This is at the heart of our purpose as a company: to push the boundaries of science to deliver life-changing medicines.
We invest in distinctive science in three main therapy areas where we believe we can make the most meaningful difference to patients: oncology; cardiovascular and metabolic diseases; and respiratory, inflammation and autoimmunity. Our science exploits our rare combination of capabilities in small molecules and biologics, immunotherapies, protein engineering technologies and devices. These are reinforced by a strong focus on translational science and personalised healthcare capabilities. We build on our own capabilities by collaborating with world-renowned scientists and academic institutions and partnering with like-minded science-led companies.
Through leading in science, we are confident that we can transform the lives of people around the world and deliver value to our shareholders.