Position: CTM Coordinator / Specialist
Principal Responsibilities:
• Maintain up to date inventory status of all investigational material
> Assist clinical and manufacturing in preparing CTM demand and forecasts
> Assist manufacturing in determining labeling schedule
> Track actual vs. planned CTM usage and alert manufacturing to deviations
> Work with 3rd party storage and distribution vendors to identify protocol requirements and establish level of service resulting in efficient and timely contractual relationships
> Assist clinical and manufacturing in evaluating 3rd party storage and distribution options
• Ensure adequate material supply for investigational sites at all times
> Process material requests for shipments
> Schedule shipments
> Document material chain of custody
> Document and ensure appropriate storage conditions for investigational material
> Investigate and implement corrective actions for shipment issues
• Ensure investigational drug is inventoried, shipped and stored in compliance with appropriate cGMP regulations.
Desired Skills/Education:
• Previous experience maintaining clinical supply chain
• Knowledge of cGMP regulations as they pertain to clinical trial material
• 4 year college degree required
External/Internal Interactions:
• Coordinate investigational material supply with internal manufacturing
• Coordinate site demand tracking/forecasting using data supplied by internal clinical team
• Coordinate investigational material shipping for domestic and international clinical sites
Contact:
Email resume to jobs@biothera.com. No calls please.