Clinical Data Manager
1 month ago
Requirements:
BS/BA in scientific discipline At least years of clinical data management experience in a pharmaceutical/biologics/biotechnology company Experience working in clinical drug development through Phase in an outsourced CRO model while serving as program level DM lead; experience with drug development in rare diseases preferred. Expert knowledge of eClinical processes, efficient design/build of an EDC data management system and other Clinical Trial/Data Management Systems Experience leading initiatives/projects for SOP, process and standards development within clinical data management. Expert knowledge and understanding of regulations and industry/adopted data standards such as CDISC, SDTM, and CDASH, with experience in overseeing study level SDTM implementation and validation. Experience working with Medidata Rave Experience using standardized medical terminology, including MedDRA and WHODrug Experience working with MSOffice Suite (Excel, Word, PowerPoint) and familiarity with MS Project Excellent written and oral communications skills Highly motivated and flexible, with excellent organizational, time and project management skills Ability to work independently and as part of a multi-disciplinary team. Understanding of ICH GCP as well as general knowledge of industry practices and standards Knowledge and understanding of regulatory requirements and expectations for clinical data systems including CFR Part-
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