GCS Associate - Safety Distribution Associate

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

Location: Warsaw or Cracow

The Global Clinical Solutions Associate is a member of the Clinical Operations Global Clinical Solutions Team, and is actively support Clinical Operations by ensuring the population and availability of complete, high quality data from Clinical Operations processes and systems and ensuring services are delivered according to time, cost and quality best standards.

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 - Safety Distribution Associate is expected to be able to take the following roles within the team:

  • Country coordinator - is responsible for safety reports submission to Investigators and Ethics Committees by:
    o submitting safety reports according to regulatory timelines and requirements
    o serving as subject matter expert Safety Submission area for particular countries,
    o cooperation with local Patient Safety Managers for alignment on regulatory requirements understanding
  • Project team member - actively participating in project tasks. Owning and keeping timelines of parts of the project

The team members will be cooperating with:

  • Local Study Team Representatives to confirm distribution method and resolve delivery issues
  • Patient Safety Managers to receive input to country regulatory requirements documentation
  • External Service Providers Representatives to discuss countries requirements and resolve issues
  • Cross-Functional Teams for project management initiatives
  • Audit and Inspection team to provide clarification on the country distribution process and answer requests

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
  • 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)

Desirable qualifications:

  • Experience in Drug Development within a pharmaceutical or clinical background
  • Experience in the development and management of Business Process to deliver business performance
  • Comprehensive knowledge of ICH GCP
  • Some experience of Quality Systems and Quality Management, including process definition and process improvement
  • 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

Knowledge of Safety Handling in Clinical Trials Process

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