Hays AG

Stellenangebot: Biospecimen Specialist (m/f/d)

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Über uns

With over 15 years of experience in the pharmaceutical and chemical industry as well as in biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated experts who want to develop professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – completely free of charge. Register with us and reap the benefits of interesting job offers that match your skills and experience.

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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

Profil

Life science Bachelor’s degree or equivalent, first experience in sample acquisition, data management, biobanking or, 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