Category
Research & Development (R&D)
Description
Job Responsibilities
Support the management of all activities associated with the supply of CTS to support Ono Clinical Trials.Communicate with external vendors before and during Clinical Study start to ensure all plans and outsourced activities are progressed efficiently to meet study timelines and to make sure appropriate output to meet study demand.Represent as the primary contact with external CTS vendors during the maintenance stage of a clinical trial when needed.With contribution from CTSM, take accountability for CTS management during the maintenance phase of a clinical trial.Key SkillsCan interact effectively at all levels within the organisation, as well as with external partners and clients.Demonstrated the ability to work independently with minimal supervision. A can-do attitude with a willingness to get actively involved.Have a meticulous eye to detail with the ability to review both data and procedures in detail and the ability to see the greater overall picture.Excellent IT Skills (PCs, Windows and Microsoft Office).Excellent communication skills both verbal and written.RequirementsA BSc or BA degree in Life Sciences, pharmacy, chemistry or other health sciences.Prior experience working with Clinical Research vendors in the EU and/or US.Knowledge of EU and/or US regulations/guidance pertaining to the supply of IMP in clinical trials.Experience working with external Clinical Research/CTS vendors.Experience of GxP requirements, specifically in relation to Clinical Trial Supplies.Previous experience in a GMP environment or exposure to GxP principles.