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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)
By sending us your CV per E-Mail you are giving us your consent to the processing of your personal data according to our Data Privacy Policy.
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)
By sending us your CV per E-Mail you are giving us your consent to the processing of your personal data according to our Data Privacy Policy.
Projektdetails
Geforderte Qualifikationen
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Kategorie:
Medien/Design, Sonstiges