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Senior CSV Specialist

Eingestellt von Coopers Group GmbH

Gesuchte Skills: Support, Design

Projektbeschreibung

For our pharma client in Basel we are currently looking for a

SENIOR CSV SPECIALIST

This role is part of our clients Pharma Research and Early Development Digital Biomarker program.

THE PROGRAM'S FOCUS AREAS ARE:

- Design digital biomarkers: Define ways to capture clinical outcomes using sensor data collected from smartphones and wearables
- Develop apps and data processing pipeline: Establish processes, software, and infrastructure to handle big data collected from sensors in clinical trials
- Deploy digital biomarkers to clinical studies: Generate data to validate approaches and support decision making
- Analyse and interpret sensor data: Identify signals for disease severity and progression in sensor data collected from patients in trials

TASKS AND RESPONSIBILITIES:

- 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

START DATE: 01.08.2018
DUARTION: UNTIL END OF YEAR, POSSIBLE EXTENSION
LOCATION: BASEL

Are you interested to work in this challenging position? Benjamin Wenk, Talent Resourcer, is looking forward to receiving your complete profile. Please send an e-mail (see below)

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Projektdetails

  • Einsatzort:

    Basel, Schweiz

  • Projektbeginn:

    asap

  • Projektdauer:

    Until end of Year With Option for Extension

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

Coopers Group GmbH