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.
La preghiamo di leggere attentamente le informazioni contenute in questo annuncio di lavoro per comprendere esattamente cosa ci si aspetta dai potenziali candidati.
This role entails:
- 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:
- 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.
Mostra le tue capacità professionali all'azienda, compila il form e lascia un tocco personale nella lettera di presentazione, aiuterà il recruiter nella scelta del candidato.