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As part of the HSM team, be responsible for intake/approvals for biospecimen sourcing (global sourcing). Ensures Service Level Agreement (SLA) delivery and alignment with global standards.
This Role Entails
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- Support the local SLA process
- Manage local intake, prioritization, resourcing, and SLA adherence for all materials
- Perform/delegate approvals for acquire/use/transfer/destruction of materials
- Support HDRP (formerly CENTRAXX) administration (lifecycle management)
- Italy regulatory process for import-export and workflows.
- Run provider performance reviews
- Support internal and external stakeholders with human sample access queries
- Ensure Human Sample operations including (fresh) sample reception, storage, tracking, distribution, and destruction
- Support the lead of the team for local audits
- Provide training and documentation as needed for the HSM processes
- Contribute to quality management and process development
This Role Requires
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- PhD in Biology, Life Sciences or related field or Masters with several years of experience in Biology/Life Sciences in a CRO, Biotech or Pharma organization
- >>2-4 years experience in human sample management, quality and compliance (biosample acquisition and management)
- Project management skills, including planning and organization
- Knowledge and experience with human sample compliance and all applicable laws/regulations. Understanding of clinical sample governance
- Ability to work cross-functional, multi-disciplinary and across multiple projects simultaneously
- Experience in implementing workflows for ethical and regulatory compliance
Strong communicator in Italian and English
Ability to work independently in a fast-paced, team-based environment.
Ability and experience in working in a matrix environment.
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