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Senior Digital Biomarker Validation Specialist

  • Salaire: CHF84 - CHF94 per hour
  • Type d'emploi: Contract, Full-time
  • Lieu: Basel
  • Secteur: Consulting, Other, Pharma & Life Sciences
  • Date de mise en ligne: 14/06/2018
  • Référence du poste: J388077ANWY-140618
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Senior Digital Biomarker Validation Specialist

Experis IT is Europe's leading IT&T recruitment agency. We are dedicated to connecting talented individuals with Business opportunities across several professional sectors, with IT being at the heart of our operations.

On behalf of our client, one of the market leaders in the field of medical devices with HQ in Basel, Switzerland, we are looking for a Senior Digital Biomarker Validation Specialist.

This is a contracting position from the 1st of August until the end of this year.

Our client is looking for a number of roles to support the Pharma Research and Early Development (pRED) Digital Biomarker program. This program's objective is to develop digital biomarkers for the company.

What your role will be:

  • Integrate a project team working in the fast pace area of Digital Health
  • Liaison between business and development team
  • Create or support the creation of project based documentation for computerized systems validation:
    • Creating risk assessments, validation plans and reports.
    • Collect user requirements, write functional specifications
    • Deliverables of the Specify and Design Phase
    • Create or support the creation of User Guides, Admin Guides
  • Responsible for reviewing (formally or informally) CSV deliverables:
    • Review design specs and make sure they cover requirements
    • Review System Test + UAT scripts, liaise with test team
  • Lead and coordinate testing activities:
    • Plan and monitor SAT and UAT with testers and users
    • Support and coordinates SAT and UAT, as required
    • Ensure requirements traceability
  • Support IT and Quality while discussing CSV strategy
  • Providing validation and Compliance advice and guidance to project managers and project tea

What you bring to the table:

  • +7 years of experience with computer systems validation (CSV) projects and all related deliverables
  • +7 years of experience with computer system and device qualification
  • 1-2 years of experience in mobile application development and/or validation
  • Extensive technical background (+10 years' experience in the Informatics/Information Management area) and Software Development Lifecycle
  • Extensive knowledge of the full Lifecycle of an Information Management (IM) project and supporting a project methodology
  • Good and up-to-date knowledge of medical device regulatory framework
  • English language proficiency

It would be an advantage if you also have:

  • Experience in the Pharmaceutical industry
  • Experience in Medical Device certification process

Location: Basel, Switzerland

Duration: 01.08.2018 - 31.12.2018 (extension might be possible)

Additional Information: 100% workload, travelling is not required, 20-member team, department PXI pREDI

If you are a result oriented person who is currently looking for an exciting new position the job description applies to your skills, then we look forward to receiving your application!

If you aren't sure whether you should apply or have any questions, please call Nastasia Whyte on +41 61 282 22 13.

Not the right job for you? Since new jobs are coming in every day just give us a call under +41 (0)61 282 22 13. Experis, the leading IT recruitment agency in Switzerland has many open jobs, just browse our website now to find interesting professional opportunities!

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