One of our clients is looking for a Biospecimen Specialist to support the acquisition, management and documentation of biological specimens and associated sample data. The role combines biospecimen/sample management, clinical operations, data management and regulatory compliance , with close collaboration across internal teams, external vendors and other stakeholders.
Responsibilities
- Manage end-to-end biospecimen acquisition , from gathering requirements through sample delivery.
- Support the collection, handling, processing, tracking and management of biological samples in line with established SOPs and quality requirements.
- Coordinate with external vendors, including reviewing quotations, supporting Scope of Work activities and Material Transfer Agreements (MTAs), and facilitating purchase requisitions.
- Manage biospecimen and associated test data, including data transfer, review, transcription, quality checks and discrepancy resolution.
- Maintain accurate sample and study information within LIMS and other validated systems .
- Monitor acquisition activities, timelines and deliverables, proactively identifying and resolving issues.
- Collaborate with internal and external stakeholders to ensure project milestones and sample requirements are met.
- Maintain required legal, regulatory and ethics documentation , ensuring compliance with applicable procedures and standards.
Requirements
- Bachelor’s degree in Life Sciences or a related field with 1–3 years of relevant experience in biospecimen/sample acquisition, sample management, biobanking or a related area; or a Master’s degree with relevant practical experience.
- Hands‑on experience with biological sample collection, handling, processing, tracking and/or biobanking workflows .
- Experience supporting or managing clinical trial operations, protocols and deliverables across study timelines.
- Good understanding of GCP/ICH-GCP , FDA and/or EMA guidelines, IRBs/IECs and ethical principles governing clinical research.
- Understanding of data privacy requirements such as GDPR and/or HIPAA , particularly regarding patient consent, specimen handling and clinical data.
- Strong attention to detail and experience working with complex data and documentation.
- Professional working proficiency in English .
Nice to have:
- Experience with LIMS or other validated systems .
- Knowledge of regulatory requirements within diagnostics.
- Experience with legal agreements such as Material Transfer Agreements (MTAs) .
Biospecimen Specialist Arbeitgeber: Actalent
Actalent ist ein hervorragender Arbeitgeber, der seinen Mitarbeitern in Burnsville, Minnesota, eine dynamische und kollaborative Arbeitsumgebung bietet. Mit einem starken Fokus auf technische Exzellenz und kontinuierliche Verbesserung ermöglicht das Unternehmen seinen Mitarbeitern, an innovativen Projekten im Bereich der Luft- und Raumfahrttechnik zu arbeiten und sich beruflich weiterzuentwickeln. Die angebotenen Vorteile, einschließlich flexibler Arbeitszeiten, umfassender Gesundheitsleistungen und einer 401(k)-Rentenplanung, tragen dazu bei, dass Mitarbeiter sich geschätzt und unterstützt fühlen.
