<p>Collaborate with internal and external partners, including Biostatistics, Statistical Programming, Clinical Operations, Clinical Research, Quality Assurance, Global Patient Safety and Risk Management, and Regulatory Affairs; CROs, central and local laboratories, and other vendors Establish cross-functional, internal data review plans, coordinate data cuts/transfers, conduct data reviews and oversee data review of team members Collaborate with Statistical Programming on SDTM validation efforts, performing supplemental review of validation reports, SDTM Reviewer Guides and define.xml files as required, and coordinating feedback to CRO while driving internal decision-making and overseeing issues to resolution Participate in the training of external vendors and site staff as needed Participate in the drafting and/or review of timelines consistent with company goals and ensure all deliverables and milestones are met BS/BA in scientific discipline or equivalent amount of combined educational and work experience is required. Exceptional candidates may be considered with less years depending on experience and education. At least 10 years of clinical data management experience in a pharmaceutical/biologics/biotechnology company Experience working in clinical drug development through Phase 3 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 21 CFR Part 11 NDA/MAA experience</p>