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).