Digital Biomarkers Computer Systems Validation Expert

Itech Consult Ag | Basel

Date listed

2 months ago

Employment Type

Full time

Keywords: python

Digital Biomarkers Computer Systems Validation Expert - data analysis methods and algorithms - scientific or engineering, SCRUM

Role: For our client in the Pharma industry based in Basel we are looking for a Digital Biomarkers Computer Systems Validation Expert. 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 our patients. Our organization is growing, and we are shaping the digitization of Pharma R&D. We will continue to be the best scientific Informatics partner in the pharmaceutical industry, and need innovative, dedicated people from a wide variety of backgrounds as we realize our vision. Digital tools, such as smartphones or wearables, can now continually measure and collect vital health information - or "Digital Biomarkers" - from patients. Digital biomarkers are changing how future medicines will be developed and could lead to more personalized use of new medications that will transform the lives of patients. Advances in wearable devices, such as phones, watches, textiles or delivery devices, which track a patient's vital signs and monitor for symptoms all have the potential to vastly accelerate clinical development. Preferably, we are looking for a CSV Expert responsible for data analysis algorithms validation to integrate an ongoing backend validation project. We are open from professionals, up to seniors and just transfer responsibilities regarding the CVs/ experiences we receive. Areas of responsibility: - Integrate a project team working in the fast pace area of Digital Health - Liaison between business and development team - Create project-based documentation for computerized systems validation - Risk assessments, validation plans and reports - User requirements - Functional specifications - User Guides, Admin Guides - Other deliverables of the Specify and Design Phase as defined in the validation plan - Responsible for creating and / or 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 coordinate SAT and UAT, as required - Ensure requirements traceability - Support IT and Quality while discussing CSV strategy - Provide validation and Compliance advice and guidance to project managers and project team Professional and technical requirements: - Expertise with computer systems validation (CSV) projects and all related deliverables (preferred also in kick starts) - Ability to understand and document data analysis methods and algorithms - scientific or engineering background - Expertise in computer systems and device qualification, ideally Cloud environment - Experience in regulated software development processes within the Pharmaceutical or other regulated industry - Expertise in modular software development for ease of code reuse - Technical background with experience in the Informatics/Information Management area and Software Development Lifecycle - Experience in agile software development methodology (SCRUM preferred) - Excellent written and spoken English language skills Nice to Haves: - Experience of the client (Pharma) internal CSV guidelines and processes - Experience in using HP Application Lifecycle Management (HP ALM) - Expertise in hands-on mobile software development - Experience in coaching software developers - Experience in Python

Reference no: 919593 AD Role: Digital Biomarkers Computer Systems Validation Expert Industry: Pharmaceutical industry Workload: 100% Location: Basel, Switzerland Start date: September 2020 Duration: until 30.06.2021, with possible extension

About us: ITech Consult is a certified ISO 9001:2015 Swiss company with offices also located in Germany and Ireland. ITech Consult is specialised in delivering IT candidates for contract work. We were founded in 1997 by IT professionals; hence we well understand what it means to be professionally supported in your search for a new project and being employed.

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