Biospecimen Data Operations Specialist

Accountable for accurate and compliant study configuration in LIMS (products, categories, test plans, cohorts, schedules). Accountable for corresponding system configurations, dose schema alignment, and blinded data safeguards. Accountable for clinical data management interface setup, template selection, mapping integrity, and transfer readiness. Accountable for TrialBridge imports, quarantined record review, and discrepancy release. Accountable for inventory files and external biorepository interface initiation, monitoring, and shipment registration validation. Accountable for work order/test order creation and export template governance. Accountable for BSM Plan generation, version control, and DARS readiness inputs. Accountable for shipment readiness controls (no discrepant samples shipped). Accountable for study status transitions (Approved/Active/Completed) and end-of-study system closure. Accountable for documentation completeness across study lifecycle (data flow maps, contact lists, study-level logs).