The Drug Supply Coordinator is responsible for managing designated Clinical Supply Chain Management team activities for the Fisher Clinical Services (FCS} Clinical Ancillary Management unit. This position will work with FCS clients, packaging sites, depots and Clinical Supply Chain Managers to understand the supply chain requirements and manage clinical ancillary trial materials on the study level with a primary focus on inventory management at clinical trial sites and depots.
- Ensures that clinical trial ancillary materials are available for patients participating in clinical trials by analyzing current and forecasted material usage and projecting inventory availability across the clinical trial supply chain.
- Formulates recommendations that ensure continuity of supply and communicating those recommendations with all key personnel involved with the packaging. distribution and storage of the clinical trial materials
- Monitors inventory levels at the study depots and performs calculations necessary that support appropriate action to ensure that depots are appropriately stocked. Analyzes clinical ancillary supply material levels at sites and triggers manual shipments as required
- Coordinates label design and translation activities in accordance with the study project plan
- Manages inventory, and shipment delivery of clinical trial ancillary materials and works with appropriate internal and external parties to address any issues which might impact the timely delivery of supplies to distribution depots and clinical trial sites
- Supports expiry date management by identifying inventory to be extended, supporting the extension process and updating IRT status as appropriate
- Coordinates return, destruction and completes reconciliation of ancillary products on assigned studies and proactively escalating issues to appropriate parties.
- Documents and maintains calculation of ancillary product use and supply based on varying levels of available data from Sponsors. lVR vendors and Internal FCS departments.
- Identifies and/or recommends process improvements based on understanding of Clinical Trial Supply Chain Management best practice principles and appropriately documents and revises or develops associated training materials
- Acts as back up for other members of the supply chain team.
- Works with both internal and client Project teams to ensure consistent communication of clinical trial material supply status and potential risks. Produce reports and metrics as agreed for study tracking.
- Enters and monitors Clinical Trial Supply Chain supplies in internal proprietary systems (GPM) utilizing existing FCS documentation methods, practices and policies
- Utilizes sponsor documentation methods, practices and policies, as required, that are in conjunction with, but do not contradict FCS' Standard Operating Procedures
- Implements plans to distribute ancillary supplies to global clinical trials using sound supply chain techniques
- Leverages the Inventory management capabilities of the Interactive Response Technology (IRT), if available 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
- Attends relevant client-related meetings and appropriately represent status of the Clinical Supply Chain
- Maintains documents according to guidelines and relevant procedures
- Conducts activities ln a safe and efficient manner
- Other duties may be assigned to meet the needs of the business
- Minimum Requirements:
- Bachelor's degree or equivalent work experience required. Degree in clinical supplies management or science—relate field preferred.
- Minimum of two years Project Management experience, either in distribution. lRT, and/or Packaging
- Strong project management skills
- Exemplary computer skills including high proficiency in Microsoft Excel (Macros) and Access
- Demonstrated experience with multiple global clinical trials
- Understanding of pharmaceutical industry and/or clinical trial supply chain management preferred
- Understanding of inventory management practices preferred
- Experience procuring and/or managing ancillary and/or medical device supplies preferred
- Strong customer service orientation
- Strong communication skills
- Exemplary teamwork and interpersonal skills
- Strong organizational and self-management skills
- Ability to independently manage priorities and workday in a remote setting
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