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Senior Digital Biomarker Validation Specialist
Eingestellt von Harvey Nash IT Recruitment Switzerland
Gesuchte Skills: Support, Design
Projektbeschreibung
For our client in BASEL we are looking for a SENIOR DIGITAL BIOMARKER VALIDATION SPECIALIST for a 5-MONTH contract.
DURATION: 01/08/2018 TILL 31/12/2018
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)
DURATION: 01/08/2018 TILL 31/12/2018
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)
Projektdetails
Geforderte Qualifikationen
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Kategorie:
Medien/Design, Sonstiges