Digital Biomarkers Computer Systems Validation Expert (f/m/d)

Digital Biomarkers Computer Systems Validation Expert (f/m/d) – CSV /SCRUM/ SW Development / Cloud / English

Project:
For our customer a big pharmaceutical company in Basel we are looking for a highly qualified Digital Biomarkers Computer Systems Validation Expert.

Background:

The Client`s Research and Early Development Informatics team is the bridge between digital technology and science. They help drive medical innovation and are integral to the realization of truly Personalized Healthcare and the development of innovative treatments for our patients. Their organization is growing, and they are shaping the digitization of Pharma R&D. They 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. The Digital Biomarker program’s objective is to develop digital biomarkers. Here we are looking for a Computer Systems Validation Expert. We are looking for a CSV Expert to take on the Validation Lead role in a new back-end validation project. This person will be responsible for the CSV validation of systems including data analysis algorithms, working in close collaboration with technical team members responsible for software development and Data analysts, responsible for algorithm development. The client is open from professionals, up to seniors and just transfer responsibilities regarding the CVs/ experiences we receive.

Tasks & Responsibilities:

• Validation lead position for clinical data processing platform
• Creating validation documentation
• Foundation of strategy
• Supporting Data analysis team
• Responsible for validation, lead other validation resources
• Also includes Project management components

Must Haves:

• IT-related Background with experience in that field
• Min. 3-5 years Expertise with computer systems validation (CSV) projects and all related deliverables (preferred also in kick starts)
• Min. 3-5 years, Experience in regulated software development processes within the Pharmaceutical or other regulated industry
• Expertise in modular software development for ease of code reuse
• Experience in agile software development methodology (SCRUM preferred)
• Ability to understand and document data analysis methods and algorithms – scientific or engineering background
• Expertise in computer systems and device qualification, ideally also Cloud environment
• Technical background with experience in the Informatics/Information Management area and Software Development Lifecycle
• Excellent written and spoken English language skills

Nice to Have:

• Experience in coaching software developers
• Experience in Python
• Expertise in hands-on software development
• Experience in using HP Application Lifecycle Management (HP ALM)

Reference Nr.: 921982SDA
Role: Digital Biomarkers Computer Systems Validation Expert

Industrie: Pharma
Workplace: Basel
Pensum: 80 – 100%
Start: 01.11.2022
Duration: 18++
Deadline: 28.09.2022

If you are interested in this position, please send us your complete dossier via the link in this advertisement. If this position does not fit your profile and you wish to be considered for another position directly, you can also send us your dossier via this ad or to jobs[at]itcag[dot]com.

Contact us for more information about our company, our positions or our attractive Payroll-Only programme: +41 41 760 77 01.

About us:

ITech Consult is an ISO 9001:2015 certified Swiss company with offices in Germany and Ireland. ITech Consult specialises in the placement of highly qualified candidates for recruitment in the fields of IT, Life Science & Engineering.

We offer staff leasing & payroll services. For our candidates this is free of charge, also for Payroll we do not charge you any additional fees.