For our customer located in Basel/Switzerland we are currently looking for (m/f/d) a Junior Validation Expert - Digital Biomarkers Program
- Type of placement: months, external contract with possible long term extension
- Company: 6 major Pharma company in Basel area
- Salary: level 2, please ask us for the exact rate range
(monthly all in salary levels in CHF, level1= 5-10k , level2=10-15k, level3= >15k)
Our clients Pharma Research and Early Development Informatics team is the bridge between digital technology and science. We help drive medical innovation and are integral to the realization of truly Personalized Healthcare and the development of innovative treatments for patients.We are shaping the digitalization of Pharma R&D at our customer, and we are growing. For our vision to come true, we need innovative, dedicated people from a wide variety of backgrounds.
- Start date: 18.03.2019
- Latest start date: 08.04.2019
- End date: 30.09.2019
- Extension: An extension might be possible, but would need to be approved.
- Work location: Basel
- Workload: 100%
- Travelling: Not required
- Team size: 20 team members
- Department: PXI (pREDi, Digital Biomarker Program)
Tasks and Responsibilities
- Integrate a project team working in the fast pace area of Digital Health.
- Responsible for creating and / or reviewing (formally or informally) CSV deliverables:
- Review design specs and make sure they cover requirements
- Create 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
- Create or support the creation of project based documentation for computerized systems validation:
- User requirements
- Functional specifications
- User Guides, Admin Guides
- Other deliverables of the Specify and Design Phase as defined in the validation plan
- Coordination and tracking of activities associated with the delivery of documentation, e.g. adequate review and approval process is followed
- Support the project team in documenting testing activities and setting up appropriate test cases and scripts
- Support the Informatics Project Leader in coordinating and attending project team meetings, writing of meeting minutes and follow-up of action items
- Analyzing existing documentation and consolidation
- Support IT and Quality while discussing CSV strategy
- Provide validation and Compliance advice and guidance to project managers and project team.
- Experience with computer systems validation (CSV) projects and all related deliverables
- Technical background (+3 years’ experience in the Informatics/Information Management area) and Software Development Lifecycle
- Extensive knowledge of the MS Office tools
- Good knowledge of the full Lifecycle of an Information Management (IM) project and supporting a project methodology
- Flexible and able to work in a distributed matrix organization
- Team player with very good communication skills
- Excellent written and spoken English language skills
Nice to Haves
- +++ Experience of Roche internal CSV guidelines and processes.
- +++ Experience in using HP Application Lifecycle Management (HP ALM)
- +++ Experience in the Pharmaceutical industry
- +++ Experience in Mobile health validation
Kindly be informed that our customer is located in Switzerland. Therefore only applications within the EU or candidates holding Swiss work permission are required.
The SymplyVision-Team is looking forward to receiving your application (Word file is highly appreciated).