Biospecimen Specialist (m/f/d)

Work Selection AG; Risch-Rotkreuz; Vor Ort; CHF 120.000 - 150.000; Vollzeit

Benefits dieser Stelle

On-site parking

Staff meals

Welcome Days onboarding

Professional development support

Retail discounts

Fuel card discounts

Zusammenfassung

Work Selection AG sucht für Roche Diagnostics in Rotkreuz einen Biospecimen Specialist. Die Position ist als 12-monatige befristete Anstellung mit hoher Verlängerungswahrscheinlichkeit vorgesehen.

Sie arbeiten im BAM-Team in Rotkreuz und verantworten Beschaffung sowie Management von Biospecimens gemäß SOPs, GMP/GCP und regulatorischen Vorgaben. Fokus auf Datenqualität, Compliance und termingerechte Bereitstellung.

Qualifikationen

• Bachelor- oder Masterabschluss in Life Sciences mit 1–3 Jahren relevanter Erfahrung.
• Praktische Erfahrung in biologischer Probensammlung, Handling und Biobanking-Workflows gemäß SOPs.
• Nachweis von klinischen Studien-Operationen von Start bis Abschluss gemäß Zeitplänen.
• Fundierte Kenntnisse zu regulatorischen Rahmenwerken (FDA/EMA), GCP/ICH-GCP.
• Kenntnisse zu Datenschutzrechten (GDPR, HIPAA) und Datenintegrität.
• Englischkenntnisse auf CEFR B2-Niveau

Aufgaben

• Probenakquisition und Compliance von End-to-End-Prozessen gemäß Vorgaben.
• Datenmanagement und LIMS-Operationen für Probenlebenszyklus.
• Projektüberwachung und Stakeholder-Engagement, termingerechte Deliverables.
• Dokumentation und regulatorische Aufrechterhaltung nach BAM-Verfahren.

Kenntnisse

Biobanking experience

Clinical trial operations

Regulatory knowledge (FDA/EMA)

Data privacy knowledge (GDPR/HIPAA)

English proficiency (CEFR B2)

Ausbildung

Bachelor's degree in Life Sciences or equivalent

Master's degree in Life Sciences or equivalent

Jobbeschreibung

As a first-tier supplier to our renowned business partner Roche Diagnostics in Rotkreuz, we are currently looking for a motivated and dedicated Biospecimen Specialist for a temporary assignment of 12 months, with high probability of extension.

The successful candidate will join the Biospecimen Acquisition and Management (BAM) team in Rotkreuz. BAM is a service organization that has four teams situated across Europe and North America and that uses global capabilities with local support structures to drive integrated biological specimen solutions that accelerate the Roche Diagnostics strategy.

The Biospecimen Specialist is responsible for the acquisition and/or management of biospecimens and all associated sample/test data in compliance with local regulatory requirements, quality, business, and industry best practices/standards.

The ideal candidate is a highly motivated, organized, and solution-driven team player with meticulous attention to detail. Additionally, Roche is seeking someone who is committed to ensuring the highest quality, accuracy, and timeliness of biospecimen deliverables. The candidate possesses strong verbal and written communication skills, including the ability to consistently follow complex protocols, along with excellent data handling capabilities.

Tasks und Responsibilities

• Biospecimen Acquisition und Compliance: Lead end-to-end biospecimen acquisition by gathering requirements, developing Scope of Work, reviewing and negotiating vendor quotes and Material Transfer Agreements, and facilitating purchase requisitions, ensuring strict adherence to quality, compliance, and industry best practices.
• Data Management und LIMS Operations: Manage the complete biospecimen data lifecycle, including data transfer, review, transcription, quality/consistency checks, and resolution of discrepancies. Assume accountability for accurate data entry and execution of all data functions within validated Laboratory Information Management Systems (LIMS).
• Project Oversight und Stakeholder Engagement: Proactively monitor sample acquisition progress, identify and resolve issues, and assume responsibility for the accuracy, quality, and timeliness of deliverables. Effectively interface with internal and external stakeholders to establish timelines and meet defined project goals.
• Documentation und Regulatory Maintenance: Ensure continuous process compliance, including the accurate collection and maintenance of all required legal, regulatory, and ethics documentation according to established BAM procedures.

Must Haves

• Bachelorund#39;s degree in Life Sciences or equivalent with 1–3 years of relevant experience in sample acquisition, data management, and biobanking; OR Masterund#39;s degree in Life Sciences or equivalent with relevant experience in sample management, biobanking, or a related field
• Demonstrated hands-on experience in biological sample collection, handling, processing, tracking, and biobanking workflows according to standard operating procedures (SOPs)
• Proven track record managing clinical trial operations, protocols, and deliverables from study start-up to completion, adhering to defined project timelines, milestones, and scope
• Strong working knowledge of global regulatory frameworks (FDA and/or EMA guidelines), Good Clinical Practice (GCP/ICH-GCP), institutional review boards (IRBs/IECs), and bioethical principles governing clinical research
• Solid understanding of data privacy requirements and regulatory standards (e.g., GDPR, HIPAA) governing patient consent, specimen handling, and clinical data integrity
• Professional working proficiency in English (minimum CEFR B2 level or equivalent), with strong written and verbal communication skills for clinical documentation and reporting

Nice to Haves

• Experience in LIMS or other validated systems
• Understanding of regulatory requirements related to diagnostics
• Knowledge of Good Clinical Practice, ethics, and data privacy
• Understanding or experience in the negotiation of legal contracts (e.g., Material Transfer Agreements)
• German language skills

Benefits

• Become part of one of the most prestigious pharmaceutical companies and actively shape the future of healthcare
• Experience a work culture that promotes diversity and inclusion and where all employees feel valued
• Work on a state-of-the art campus featuring green spaces, meeting areas, and an inspiring atmosphere
• Work with modern and up-to-date tools in an innovative work environment
• Start with a professional onboarding process and a thorough introduction to your new role during the Welcome Days
• Benefit from financial support for your professional development plans
• Enjoy a selection of high-quality meals in modern staff restaurants
• As part of a sustainable mobility concept, on-site parking spaces are available to you (subject to eligibility criteria)
• Take advantage of unbeatable, year-round discounts at renowned retailers and over 200 top brands
• Benefit from fleet discounts when purchasing new cars or receive constant fuel discounts with our fuel card

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