Pre-Production Specialist, Global Operations
Core
Manage order processes, ensure compliance, and maintain accuracy across documentation and systems for clinical trial materials in a regulated pharmaceutical environment.
Role type
Pre-production operations specialist (clinical supply)
Builds
Clinical Trial Materials (CTMs) for sponsors' studies
Domain
Pharmaceutical clinical supply chain
Required skills
order management, batch record creation, data exchange management, order auditing, material availability checking, manual business continuity, kit number assignment, schedule change monitoring, SOP compliance
Preferred skills
clinical trial packaging experience, clinical supply chain systems knowledge, GCP/GMP understanding
Technologies
SupplyFlex Aggregator, Clinicopia, Excel
Responsibilities
Create site packaging and/or shipment orders; Perform study set up, design, and writing of batch records; Manage client demand received via various data exchange methods; Review and audit assembly order and shipment order packets for accuracy; Check availability and select bulk material to order; Generate assembly and shipment orders to meet client demand; Execute manual business continuation process during system outages; Assign kit numbers to orders and shipments; Monitor requesting patterns to flag schedule changes; Ensure orders comply with all applicable SOPs and PADI.