Biospecimen Specialist

Biospecimen Specialist: Data Management / LIMS / Biobanking / global regulatory frameworks / GDPR / HiPAA / GCP /SOP/ English / Deutsch
Background:

You would be joining 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 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 Perfect Candidate:
The perfect candidate is a highly motivated, organized, and solution-driven team player with a meticulous attention to detail. Additionally, we are looking for someone who is committed to ensuring the highest quality, accuracy, and timeliness of biospecimen deliverables. The perfect candidate has strong verbal and written communication skills, including the ability to consistently follow complex protocols and excellent data handling capabilities.

Tasks & Responsibilities:
•Biospecimen Acquisition & 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 & 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 & 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 & 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:
•Life science Bachelor's degree or equivalent, 1-3 years relevant experience in sample acquisition, data management, biobankingOr, Life science Master's degree or equivalent, some experience in sample management, biobanking or related area
•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 Practices, Ethics, Data Privacy
•Understanding or experience in negotiation of legal contracting e.g: Material Transfer Agreements
•German

Reference No.: 925375
Role: Biospecimen Specialist
Industry: Pharmaceuticals
Location: Rotkreuz
Workload: 100%
Start: ASAP (January 4, 2027) Duration: 12+ Months
Deadline: October 9, 2026

If this position has piqued your interest, please send us your complete resume. If this position does not quite match your profile and you would like to receive other positions directly, you can also send us your resume 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 program: +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 specializes in placing highly qualified candidates for temporary staffing in the fields of IT, life sciences, and engineering. We offer temporary staffing and payroll services. This is free of charge for our candidates, and we do not charge any additional fees for payroll services.