Warsaw, Mazowieckie, Poland
Over 11 years of experience. Leads and provides direction to Study with members from R&D Supply Chain, Clinical Development and external partners. Ensures the team delivers clinical supplies effectively and consistently, balancing cost and risk to supply with expert input and support from cross functional groups. Understands and translates clinical study protocol requirements into demand for drug product within a clinical study. Authors the drug supply section of Clinical Study Protocol and leads development of label text. Uses simulation tools and supply chain expertise to design optimized, lean supply chains for individual studies and ensure delivery of the end to end supply of materials to meet study needs. Uses forecasting tools to have the appropriate amount of drug at the appropriate location during the study duration. Defines IRT user requirements, sets up IRT and ensures timely go-live for individual studies. Uses IRT to track recruitment and adjust IRT parameters to accommodate any changes in study scope and design. Collaborates with CRO partners in development of pack design and reviews the technical part of the outsourcing contract. Reviews changes to the contract with CRO partners and Sourcing Managers as necessary. Works within GCP and GMP Quality Management System, including managing deviations, complaints, change controls as appropriate, and provides documentation to electronic trial master files. Monitors the budget for individual study supply activities and materials for the project. Phase II, Ill and IV studies in the area of rheumatology, dermatology, oncology and neurology.
Logistics Specialist responsible for Coordination of the process of distribution of medicines for clinical trials in Poland and CEE, close cooperation with Investigational Sites; Involved in the process of buying drugs on Polish territory; Working with suppliers and customers; Organize and supervise the transport of medicines (shipments, temperature deviation handling); EDC, eCRF, Xpress user of central Depot Supplier function; Organization and coordination of the manufacturing processes of IMPs & Non-IMPs, including blinding in accordance with GMP and GCP (repackaging, labeling, re-labeling, blinding); Coordinate the process of destruction and safe disposal of medicines (reconciliation); Involved in Recalls & Withdrawals process; To ensure error-free operations of all logistics functions through close cooperation with other departments of the company; Involved in a randomization process of IMPs; Validation process of IT system of manufacturing and blinding of IMPs; Negotiation the terms and conditions of contracts; Participation in internal and external audits.