Beschreibung
For our client in Basel we are looking for a Senior Digital Biomarker Validation Specialist for a 5-month contract.
Duration: till
Location: Basel
Workload: 100%
In this role your responsibilities will include the following:
. 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 team.
Must Haves:
. +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 ( 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
. Flexible and able to work on several tasks in parallel
. Team player with very good communication skills
. Excellent written and spoken English language skills
Nice to Haves:
+++ Experience in the Pharmaceutical industry
+++ Experience in Medical Device certification process
For further details please contact Beata Arciszewska (see below)