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Clinical biometry it administrator

Bern
Viatris
Web Administrator
Inserat online seit: 18 Juli
Beschreibung

Clinical Biometry IT Administrator page is loaded Clinical Biometry IT Administrator Postuler locations Switzerland Remote Office time type Temps plein posted on Offre publiée hier job requisition id R5660847 Mylan Inc. Chez Viatris, nous envisageons la santé non pas telle qu'elle est mais telle qu'elle devrait être. Nous agissons avec courage et notre positionnement unique est source de stabilité dans un monde où les besoins en matière de santé sont en constante évolution. Viatris permet à chacun dans le monde entier de vivre en meilleure santé à chaque étape de sa vie. Via trois axes majeurs:
Accès : En fournissant des médicaments de haute qualité et reconnus, quels que soient le lieu de résidence ou la situation de chaque patient.
Leadership : En favorisant l’évolution de nos activités de façon durable et le développement de solutions innovantes pour améliorer la santé des patients.
Partenariat : En valorisant notre expertise collective afin de donner accès à tous à nos produits et services.
Our global portfolio includes best-in-class, iconic brand-name products as well as global key brands; generics, including branded and complex generics; and other offerings across a wide range of therapeutic areas. We are committed to helping create healthier communities worldwide through education, outreach and better access to treatment.
For those driven to live their lives with purpose, Viatris helps employees realise their full potential by creating a collaborative culture that fosters courage and resilience. Viatris is more than just a place to work. This is a place to make a difference in the world.
The Role & What You Will Be Doing
The Clinical Biometry IT Administrator will manage and support our our Biometry systems including SAS Server/PC, Posit R studio, CDISC tools, QlikSense, GitLab tools. The ideal candidate will have hands-on experience with R, SAS, CDISC, Study Data, system integrations, a strong understanding of GCP & 21CFR part 11 compliance, Knowledge of Clinical Trials and a passion for optimizing Biometry operations through technology including AI.
Every day, we rise to the challenge to make a difference and here’s how the Clinical Biometry IT Administrator role will make an impact with the following responsibilities:
• System Administration & Configuration:
Administer and maintain Biometry systems and environments.
Manage user access, roles, permissions, and security settings.
Configure system settings and workflows in alignment with business needs.
Manage interfaces, upgrades and enhancements for the Biometry systems.
• Support & Troubleshooting:
Provide Level 3 support for system issues and user queries.
Coordinate with Biometry solution vendors (SAS, Posit, Certara etc) and Run Support team for issue resolution and system updates.
Monitor system performance and ensure high availability.
Monitor the Run Support team on support KPIs.
• Compliance & Documentation:
Ensure systems are compliant with GxP, 21 CFR Part 11, and other regulatory requirements.
Maintain system documentation, SOPs, and validation records.
Support audits and inspections by providing system evidence and documentation.
Author & review technical & testing documents for Biometry systems
Execute Qualification Test scripts like IQ and OQs.
• Project Involvement:
Participate in system upgrades, enhancements, and integration projects.
Collaborate with cross-functional teams including Clinical Operations, Quality Assurance, Reg Affairs and IT program managers and various IT support groups.
• Training & Communication:
Read existing training materials and SOPs.
Train end-users and create user guides or training materials.
Act as a liaison between business users and technical teams.
Keep abreast of the latest industry trends in Clinical Biometry & Gen AI space and apply those learnings in-house.
• People Coordination:
Liaison and partner with the IT Clinical program managers at corporate Viatris for planning and execution of biometry IT initiatives and provide inputs needed for Budget planning and Business demand capture.
Engage with Viatris Innovation and Corporate Clinical Business leads and maintain good working relationships. Be available for F2F meetings with Innovation teams.
Coordinate with IT System administrators, Run-Support teams, IT Compliance, IT Quality, IT security and Data Privacy teams as needed for biometry initiatives.
Maintain connect with Biometry vendors, keep track of Biometry licenses and compliance ann monitor any vendors or external service providers engaged for Biometry project work.
About Your Skills & Experience
For this role, we’re looking for a candidate who has an effective combination of the following qualifications, skills and experiences:
Education: MSc level or equivalent in IT discipline, Computer science or Biostats
5 years of experience of biometry systems in Pharmaceutical and biotech industries
At least 5-7yrs of total work experience in Pharma or CRO setting.
Proficient in R and SAS programming, debugging, and validation.
Experience with Posit R Studio (Connect, Workbench), SAS (Server & PC), LSAF, and EntimICE.
Skilled in system setup and maintenance for statistical computing environments.
Knowledge of Unix/Python scripting, robocopy, Jenkins, GitLab, and CI/CD pipelines.
Familiar with data visualization tools (Qlik Sense, Tableau).
Exposure to AI technologies (predictive, generative, agentic – nice to have).
Experienced in ICH GCP and FDA 21 CFR Part 11 environments.
Knowledge of CSV, CDISC standards (ADaM, SDTM), and clinical data workflows.
Understanding of early and late-phase clinical studies.
Skilled in data migration, conversion, and system integration (EDC, lab systems, Globalscape/SFTP).
Supports biometry systems: issue resolution, upgrades, access management, storage.
Excellent problem-solving, communication, and documentation skills.
Fluent in English; German or French is a plus.
At Viatris, we are dedicated to building a truly diverse, inclusive and authentic workplace, so if you’re excited about this role but your past experience doesn’t fully align with every requirement, we still encourage you to apply. You may just be the right candidate for this or other roles.
Why Viatris?
At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others. You will also have the opportunity to access excellent career progression opportunities and work-life balance initiatives.
Diversity & Inclusion at Viatris
At Viatris, diversity and inclusion are essential to our mission. The diversity we foster in all aspects of our business can be one of our greatest strengths in redefining healthcare not as it is, but as it should be. If you would like to know more about what diversity, equity and inclusion means to us, please visit https://www.viatris.com/en/Careers/Diversity-and-Inclusion
Sustainability at Viatris
Corporate social responsibility is fundamental to the Viatris mission. We work to advance responsible and sustainable operations and leverage our collective expertise to empower people to live healthier at every stage of life, recognizing that our actions affect the stakeholders and communities we serve. To learn more about our efforts, please visit https://www.viatris.com/en/about-us/corporate-responsibility
Chez Viatris, nous proposons des salaires compétitifs, des bénéfices et un environnement inclusif au sein duquel vous pouvez mettre à profit votre expérience, vos perspectives et vos compétences pour aider à avoir un impact positif sur la vie des autres.
Emplois similaires (1) Veeva Vault Clinical IT System Administrator locations Switzerland Remote Office time type Temps plein posted on Offre publiée aujourd'hui

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