Global Clinical Solutions Specialist - IRT Lead (perm/fix term)

Masovia, Warsaw, Poland / Kraków, Lesser Poland, Poland
12 May 2021
19 May 2021
Full Time
Contract Type
Experience Level
Experienced (non-manager)

Location: Warsaw or Cracow 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 - IRT Lead is expected to be able to take the following roles within the team:

  • IRT Lead - is responsible for IxRS system on a study in relation to process and system set up/ maintenance/ closure by:
    o providing clinical input to IxRS system based on CSP and consultancy with Enablement Lead/ Global Study Leader/ Study Physician and other relevant members,
    o serving as subject matter expert in IRT area,
    o leading operational aspects of IxRS system set up process to ensure system is delivered to agreed time, cost, quality and functionality,
    o leading operational aspects of IxRS 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 IxRS 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

Essential qualifications:

  • 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)
  • 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

Desirable qualifications:

  • Experience in the development and management of Business Process to deliver business performance
  • Comprehensive knowledge of ICH GCP
  • Some experience in IxRS 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