Manager, Global Clinical Solutions - IRT Lead (fix term/perm)
Locations: Warsaw or Cracow
Global Clinical Solutionsdepartment (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- IRT Lead is expected to be able to take the following roles within the team:
IRT Lead – is responsible for IRT system on a study in relation to process and system set up/ maintenance/ closure by:
o providing clinical input to IRT system based on CSP and consultancy with Global Study Team members.
Physician and other relevant members,
o serving as subject matter expert in IRT area,
o leading operational aspects of IRT system set up process to ensure system is delivered to agreed time, cost, quality and functionality,
o leading operational aspects of IRT system maintenance to ensure the system is at all time reflecting CSP and all system issues are appropriately documented, assessed and addressed.
Test Lead – responsible for creating User Acceptance Testing documentation for IRT system (Test Plan, Test Scripts, Test Report), review of the User Requirement Specification (to understand testing requirements) and tracking testing issues resolution observed during testing.
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)
Experience in the development and management of Business Process to deliver business performance
Comprehensive knowledge of ICH GCP
Some experience in IRT system delivery
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 would be an asset
Some experience in Validation/User Acceptance Testing of computerized 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 computerized systems and infrastructure
What you can expect: great working atmosphere empowering you to reach your full potential, endless development opportunities and benefits like: medical & life insurance, company car or car allowance, lunch card, annual bonus, education cost reimbursement, occasional allowances (Christmas, holiday), Multisport, anniversary awards, additional time off, pension plan, business travel insurance, recognition programme, flexible working hours.
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 authorisation and employment eligibility verification requirements.