Manager, Biospecimen Data Operations is responsible for end-to-end biospecimen operational delivery across study lifecycle, leading and managing Senior Associates, and ensuring high-quality execution of study builds, sample management plans, and integrations.
Requirements
- Deep understanding of biospecimen lifecycle, blinded/unblinded data handling, and regulatory controls.
- Enterprise systems fluency (LIMS, IRT, CDM, CLM, EBR, reporting platforms).
- Strong governance orientation (GCP/GxP, Data base lock readiness, inspection preparedness).
- Cross-functional influence across Data Management, Clinical Ops, Labs, Biobank, IT.
- Risk-based decision making and structured escalation leadership.
- Vendor oversight and performance management capability.
- Operational scaling mindset with process standardization discipline.
- Executive-ready communication and data-driven storytelling.
- Change leadership across automation and digital enablement initiatives.
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