OverviewClinical Trial Supply Specialist role at RecordatiWe are looking for a Clinical Trial Supply Specialist who will manage the IMP supply chain for assigned clinical studies throughout the multi-year study lifecycle to ensure a compliant, on-time supply of drug supply and ancillary materials, ensuring proper packaging, labelling, shipment/storage/accountability/return/destruction of drug supply (IMP, AxMP, N-IMP) in the global clinical trials sponsored by Recordati Group and ISSs.Recordati is a global pharmaceutical company with over 4,500 employees and turnover of over Euro 2bn. We develop and commercialise medicines to serve people living with common diseases, as well as those with rare diseases, in around 150 countries.Recordati aims to reimagine tomorrow with new ideas, technologies and innovations to fight diseases, and to unlock the full potential of life.Job PurposeWe are looking for a Clinical Trial Supply Specialist who will manage the IMP supply chain for assigned clinical studies throughout the multi-year study lifecycle to ensure a compliant, on-time supply of drug supply and ancillary materials, ensuring proper packaging, labelling, shipment/storage/accountability/return/destruction of drug supply (IMP, AxMP, N-IMP) in the global clinical trials sponsored by Recordati Group and ISSs.Key ResponsibilitiesManage the IMP supply chain for assigned clinical studiesEnsure that all activities are performed in compliance with GCP/GMP/GDP guidelines and other applicable regulations; and in line with the budget estimate and timelines, as defined in the approved research programsManage the CMO selection process, from identification of CMOs for the tender to Service Agreement and Quality Agreement signatureDefine the production, logistics and distribution plan to ensure delivery of IMP in accordance with planned timelines, including importation and customs clearance tasksDefine packaging specifications and kit design in collaboration with the study teamDefine RTSM system specifications with IT Digital Solutions and Data Management; involved in implementation and configuration of RTSM system and changesPrepare study plans, manuals and forms for management of IMP in collaboration with other functionsExecute and coordinate IMP complaints, batch recalls, change controlsRenew and prepare new SOPs and work instructions for IMP processesRequired EducationBachelor's degreeRequired Skills And Experience5+ years’ experience in the CRO/pharmaceutical industryBackground in clinical operations/supply chain with investigational productsGood communication skills and ability to work within a cross-functional teamKnowledge of GCP/GMP/GDP guidelines, EU and FDA regulations, drug development processAbility to work with multidisciplinary teams and coordinate internal and external stakeholders (CMO/CRO/vendors)Proven aptitude for problem solving and decision makingStrong operational skills and ability to meet timelinesGood knowledge of Veeva systems: CTMS, eTMF, QMS, CDMS, RTSMExperience reporting project details to various stakeholders within and outside the companyRequired LanguagesFluent in EnglishAt Recordati we believe in people. We are committed to creating a diverse environment and cultivating inclusion. We strive to lead with our values and help employees bring their whole selves to work and develop their potential. We are an equal opportunity employer and recruit without regard to gender, sexual orientation, gender identity or expression, national origin, age, physical or mental ability, race, ethnicity, political or religious belief.If you are looking to join a company where you can try new things, speak openly, and be bold, we invite you to apply today.
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