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Ref.10699 - Senior CSV Consultant – Digital health
To: Angela Taylor
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Senior CSV Consultant – Digital health

Basel Region

Ref. 10699
Contract position
Client's sector: Healthcare, Pharma & Chemistry

Skills: CSV, Digital Health, Regulatory, IM, SDLC
Required languages: English
Industry: Life Sciences

For our client, a leading Life Sciences company with headquarters in the Basel area, Swisslinx are searching for a highly motivated Senior CSV Consultant to join their Digital Biomarkers on a 6 month contract that is likely to be extended.

Senior CSV Consultant – Digital Health

Tasks and Responsibilities include:
• Integrate a project team working in the fast pace area of Digital Health
• Liaison between business and development team
• Create project based documentation for computerized systems validation:
? Risk assessments, validation plans and reports.
? User requirements
? Functional specifications
? User Guides, Admin Guides
? Other deliverables of the Specify and Design Phase as defined in the validation plan
• Responsible for creating and / or 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
• Provide validation and Compliance advice and guidance to project managers and project

What to bring:
• +7 years of experience with 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 of 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 mobile health regulatory framework
• Flexible and able to work on several tasks in parallel
• Team player with very good communication skills
• Excellent written and spoken English language skills

This position offers a fantastic opportunity for a candidate to gain experience with one of the world’s leading life sciences companies.

Would you like to learn more about this unique opportunity? Then please apply online. We look forward to hearing from you!

Contact person: Angela Taylor

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