The Clinical Trial Drug Supply Coordinator is responsible for managing designated clinical supply chain management team activities for Landos Biopharma Inc.’s clinical trials materials. This position will work with internal team, packaging sites, depots and Clinical Supply Chain Managers, CROs to understand the supply chain requirements and manage clinical trial materials on the study level with a primary focus on inventory management at clinical trial sites and depots (unblinded and blinded). The DSC will be completely aligned with Landos’ entrepreneurial culture fueled by innovation and growth that is encapsulated in four fundamental pillars: 1) Be bold and decisive, 2) Never give up, 3) Be solution-oriented and 4) Do the impossible.
- Responsible for the set-up and coordination of project activities related to clinical and ancillary supplies+ Independently support the delivery of the Clinical and Ancillary supplies component of assigned studies within a region or for a large global study.
- Work with staff in Clinical Trial Design & Strategy, Vendor Management, Quality Assurance, Business Development and Operations, to provide relevant clinical and ancillary supply data critical to the ability of the organization to develop plans for the successful implementation and conduct of global clinical trials.
- Ensures that clinical trial 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 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 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
- Collaborates with project team to complete and document User Acceptance Testing for Interactive Response Technology (IRT) systems.
- Monitors and manages temperature excursions of clinical trial materials according to client expectations; ensuring that both internal and external personnel are aware and takes appropriate measures appropriately disposition or replace impacted product so that patients are not impacted.
- Coordinates return, destruction and completes reconciliation of drugs on assigned studies and proactively escalates issues to appropriate parties.
- Documents and maintains calculation of drug use and supply based on varying levels of available data from Landos, IRT vendors, Sites, Depo and CROs.
- 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.
- Works with both internal and client Project teams to ensure consistent communication of clinical trial material supply status and potential risks. Produces reports and metrics as agreed for study tracking.
- Leverages the inventory management capabilities of the Interactive Response Technology (IRT) to manage site and depot inventories, releases depot shipments and follows-up on any site shipments not received.
- Attends relevant client-related meetings and appropriately represent status of the Clinical Supply Chain.
- Maintains documents according to guidelines and relevant procedures.
- Conducts activities in a safe and efficient manner.
- Maintain the confidentiality of all company deliberations and plans.
- Any new responsibilities or changes in the reporting structure as directed by the Executive Director or the CEO.
- Team-science oriented and data-driven, engendering credibility and confidence within and outside the company.
- Act in accordance with Company’s policies and in alignment with the Company’s corporate culture.
- Bachelor’s degree or equivalent required. Degree in science-related field (equivalent work experience may be considered.
- Minimum of 2 years of Project Management experience in the clinical supply area.
- Demonstrated experience with multiple global clinical trials.
- Expertise in clinical trial supply chain management methodologies.
- Experience working in GxP regulated environment.
- Strong communication skills and attention to detail.
- Exemplary computer skills, including high proficiency in Microsoft Suite including Excel, Word and MS Project as well as the Office 365 environment.
- Exemplary teamwork and interpersonal skills.
- Strong organizational and self-management skills.
- Strong project management skills.
- Strong customer service orientation.
- Ability to independently manage priorities and workday in a remote setting.