Clinical Trial Supply (CTS) Study Manager

Work Environment: *** This is a hybrid position based onsite at any of the posted locations with a minimum of 3 days onsite weekly. Relocation and mobility assistance are not provided. Main Responsibilities: Ensure efficient, cost-effective clinical trial supply planning and management for low to medium complexity studies Performs planning and forecasting of drug volume requirements Sample collection and analysis Ensures proper storage, transportation and archiving Assists with selection and management of external service providers in compliance with outsourcing strategy to ensure cost efficient and high quality services Leverages interactive response technology (IRT) system to support clinical supply management activities Authors/reviews critical study documents (e.g. study protocol, product dossiers, handling instructions, study reports) Leads or participates in global Clinical Trial Supply project meetings with internal and external team members Partners with R&D and other functions to ensure optimal use of systems and processes to support clinical trial supply chain Supports continuous improvements in clinical drug supply and revises SOPs to ensure ongoing compliance and efficient conduct of clinical trial supply activities Minimum Qualifications: Bachelors Degree in Life Sciences, Engineering, Logistics or equivalent experience 5+ years of experience in clinical supply management with the pharmaceutical industry Demonstrated knowledge of ICH-GCP regulations and the conduct of clinical studies Demonstrated knowledge of cGMP and cGDP regulations Team-player with proven effective interpersonal and communication skills