Clinical Supply Support Specialist Services - Spain - FSP

When our values align, there's no limit to what we can achieve.At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.Parexel are currently recruiting for an Clinical Supply Support Specialist Services to join one of our growing sponsors in Spain.Key Responsibilities: Clinical Supply & Inventory Planning & Execution Supply monitoring, assessment and oversight activities (risks, stocking levels, trends)Pull relevant data for metrics reporting & maintain metricsProcess requisitions and ensure timely procurement of comparator drugs & ancillary suppliesTrack and manage comparator documentation updatesClinical Supply ShipmentsInitiate non-system generated shipmentsMonitor and track comparator drug delivery schedulesCoordinate Depot transfers & site return shipmentsTemperature excursion management and resolutionClinical Supply Monitoring & Activity Documentation (Electronic Trial Master File - eTMF)Expected Document List (EDL) creationUpdate comparator IMN (Item Master Number)Update and maintain eTMF Document Management per regulatory requirementsRequest QA/QP ReleasesPack-and-label kit and sequence reconciliationInspection Readiness activitiesIRT management activities, including IRT Alert management and UAT activities IP / Ancillary Supplies Compatibility ReviewReceive and triage request, forward to FDG for reviewPerform internet searches and contact manufacturers for informationData entry of information into database (ASIST or spreadsheet) and Teams Clinical Supply SystemsManage CSS Email InboxManage IRT system access for users for all studiesComplete EDL, IRR and StiL reviews every 3 months for all studiesManage all TMF documentation uploads into VEEVAAssist in UAT testingMinimum Years of Experience: Minimum education requirements: Bachelor’s degree in a related field with an internship or prior industry work experience.2+ years of experience in the following fields:Clinical SuppliesQA/RegulatoryPrecision MedicineSupply ChainManufacturingProcurementOr equivalent research/commercial biopharma experienceIf you are interested, please apply or send your CV to marta.kuniewicz@parexel.comOriginally posted on Himalayas

When our values align, there's no limit to what we can achieve.At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.Parexel are currently recruiting for an Clinical Supply Support Specialist Services to join one of our growing sponsors in Spain.Key Responsibilities: Clinical Supply & Inventory Planning & Execution Supply monitoring, assessment and oversight activities (risks, stocking levels, trends)Pull relevant data for metrics reporting & maintain metricsProcess requisitions and ensure timely procurement of comparator drugs & ancillary suppliesTrack and manage comparator documentation updatesClinical Supply ShipmentsInitiate non-system generated shipmentsMonitor and track comparator drug delivery schedulesCoordinate Depot transfers & site return shipmentsTemperature excursion management and resolutionClinical Supply Monitoring & Activity Documentation (Electronic Trial Master File - eTMF)Expected Document List (EDL) creationUpdate comparator IMN (Item Master Number)Update and maintain eTMF Document Management per regulatory requirementsRequest QA/QP ReleasesPack-and-label kit and sequence reconciliationInspection Readiness activitiesIRT management activities, including IRT Alert management and UAT activities IP / Ancillary Supplies Compatibility ReviewReceive and triage request, forward to FDG for reviewPerform internet searches and contact manufacturers for informationData entry of information into database (ASIST or spreadsheet) and Teams Clinical Supply SystemsManage CSS Email InboxManage IRT system access for users for all studiesComplete EDL, IRR and StiL reviews every 3 months for all studiesManage all TMF documentation uploads into VEEVAAssist in UAT testingMinimum Years of Experience: Minimum education requirements: Bachelor’s degree in a related field with an internship or prior industry work experience.2+ years of experience in the following fields:Clinical SuppliesQA/RegulatoryPrecision MedicineSupply ChainManufacturingProcurementOr equivalent research/commercial biopharma experienceIf you are interested, please apply or send your CV to marta.kuniewicz@parexel.comOriginally posted on Himalayas