Biospecimen Specialist

Location: Rotkreuz

Contract duration: 12 months/possible extension

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.

Requirements:

• Life science Bachelor’s degree or equivalent.
• 1-3 years relevant experience in sample acquisition, data 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.