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.
Supports expiry date management by identifying inventory to be extended, supporting the extension process and updating IRT status as appropriate
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 Sponsors, IRT 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. Produces reports and metrics as agreed for study tracking.
Enters and monitors Clinical Trial Material (CTM) 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.
Proactively manages a program of work, supply of medication and manage risk management activities
Supports regular resource and financial tracking for assigned projects.
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
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 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
Demonstrates and promotes the company vision.How will you get here?
How will you get here? Minimum Qualifications:
Bachelors 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
* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.
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