- Applies Good Manufacturing Principles in all areas of responsibility
- Demonstrates and promotes the company vision.
- Ensures to the extent to which they can control, that clinical trial materials are available during the course of the study and that projection of these needs are continually monitored.
- Manages inventory, packaging, and shipment delivery
- Monitors and manages temperature excursions
- Coordinates return, destruction and reconciliation of ancillary supplies on assigned studies and proactively escalates issues to appropriate parties.
- Monitors inventory levels at the study depots
- Triggers manual shipments as required
- Alerts Clinical Supply Chain Manager to any concerns regarding depot inventory/site inventory
- Documents and maintains calculation of ancillary material use and supply based on varying levels of available data from Sponsors, IVR vendors and Internal FCS departments.
- Utilizes understanding of Clinical Trial Supply Chain Management best practice principles to identify and recommend new or improve existing business processes and appropriately document and revise or develop associated training materials
- Works with both internal and client Project teams to ensure consistent communication.
- Utilizes existing FCS documentation methods, practices and policies including data entry and monitoring of CTM supplies in internal systems (GPM)
- May be required to utilize sponsor documentation methods, practices and policies that are in conjunction with, but do not contradict FCS’ Standard Operating Procedures.
- Implements plans to supply study ancillary materials to global clinical trials using sound supply chain techniques
- Ability to proactively manage a program of work, supply of medication and manage risk management activities
- Devises and implements inventory management plans that have complex supply chains maintaining depot and site inventories to avoid stock outs
- Leverages the inventory management capabilities of the Interactive Response Technology (IRT) to manage site and depot inventories, release depot shipments and follow-up on any site shipments not received
- Stays abreast of relevant cGMPs, GCPs, and other regulatory requirements and ensures study management activities are aligned
- Attend relevant client-related meetings and appropriately represent status of the Clinical Supply Chain
- Maintain documents according guidelines and relevant procedures
- Conduct activities in a safe and efficient manner
- Works with FCS sales to coordinate a full-service approach with prospective clients
- Other duties may be assigned to meet the needs of the business
To perform this job successfully, the individual must be able to perform each essential duty satisfactorily. The requirements below are representative of the knowledge, skill, or ability required.
Bachelor’s degree or equivalent required. Degree in clinical supplies management or science-related field preferred.
- Exemplary communication skills
- Exemplary computer skills, including high proficiency in Microsoft Excel (Macros) and Access
- Exemplary teamwork and interpersonal skills
- Strong organizational and self-management skills
- Strong project management skills