.Clinical Supplies Project ManagerICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations.With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.The Role:We are looking for a Clinical Supplies Project Manager to provides scientific, technical and regulatory support to projects that have significant Pharmaceutical Supply Management, Chemistry, Manufacturing and Control (CMC) activities associated with them and to act as the lead on appropriate project teams. You will be managing global pharmaceutical supply for all phases and pharmaceutical development activities on-going at contract facilities with respect to technical, quality, timing and cost standpoint on behalf of our clients.- Oversee labelling, packaging and distribution activities of CMO including review and approval of labelling / packaging records and distribution plans.- Oversee recall, returns and destruction activities, as appropriate- Oversee the procurement of marketed drug product, such as comparators performed by an approved vendor and ensuring together with GRA / SSU that all study specific regulatory requirements are met.- Perform Batch Record Review and Approval, as applicable.- Manage temperature deviation, product complaints and recalls, as delegated by the client.- Gap analysis of processes relating to pharmaceutical supplies for applicable project teams.- Participates in the discussions of objectives and scope of prospective projects with potential clients.- Maintain confidentiality of management information as appropriate.- Liaise with other managers to improve the effectiveness of the organisation- Travel (approximately 10%) domestic and/or international.- Advanced English is a must.- Previous working experience with clinical supplies and IRT systems- To undertake other reasonably related duties as may be assigned from time to time.Benefits of Working in ICON:Our success depends on the knowledge, capabilities and quality of our people. That's why we are committed to developing our employees in a continuous learning culture - one where we challenge you with engaging work and where every experience adds to your professional development.At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs
