.- Budapest, Dublin, Warsaw, Lisbon, Johannesburg, Barcelona, ReadingICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.The Principal Clinical Data Science Lead role is part of the Early Phase Data Management department and is responsible for managing data management teams, studies, and programs of studies under the general direction of the Senior Manager/Director of Data Management. The Principal Clinical Data Science Lead will provide planning estimates for project scope, schedule, and resource requirements, and ensures that studies are properly managed and delivered. They will work with Clinical Operations, Biostatistics, SAS Programming, Medical Writing, and Quality Assurance to ensure that data collected during trials is managed according to corporate standards and meets regulatory guidelines for data integrity.The Early Phase service line of the company specializes in the strategic development, management, and analysis of studies and programs that support Phase 1/2a clinical development.The Principal Clinical Data Science Lead will manage a number of fast moving early phase studies or programs of studies to ensure project objectives are met within budget, to agreed timelines, and to a high level of quality. As a DMPM, you will manage a global team of clinical data management resources. The Principal Clinical Data Science Lead will provide input into CRF design, protocol review, edit check specifications, data entry conventions, monitoring guidelines, and any other study related documents and will be responsible for the maintenance, cleaning, and lock of the EDC study databases.Additional Responsibilities:Review the project contract in order to ensure that any out-of-scope work is managed promptly and efficientlyManage the overall project budget throughout the life cycle of the project, taking overall responsibilityfor cost control, timelines, and project qualityNegotiate with clients and/or external customers/departments in relations to timelines and key deliverablesT ravel (approximately 15%) domestic and/or international.TO BE SUCCESSFUL, YOU WILL NEED:6+ years of clinical data management experience (in a Clinical Research Organization or Pharmaceutical company)3+ years of experience leading studies with key responsibilities for study set-up and close-out tasksExperience with Phase I studies strongly preferred, but not requireExperience with Rave strongly preferred, but must have experience with at least one of ICON's preferred CDMS (e.G
