Senior Clinical Data Manager

Location: Home-based in the U.S. or Canada Summary: IQVIA is hiring a Senior CDM to lead data management activities of studies across all stages of clinical drug development. Join a sponsor-dedicated team, working within the environment of a Rare Disease Biopharma. Handle in-house data management work as well as review of vendor work. This position reports to the Associate Director of Data Management. Contribute/Lead data management activities in support of clinical studies, including: - eCRF development by leading cross-functional reviews of eCRF content - Database build activities, including review of edit check specifications and performance of user acceptance testing - Monitoring data collection, coding, and cleaning by vendors through tracking of study metrics and targeted data reviews - Oversight of database lock activities and ultimate archiving of study data Collaborate with internal and external partners, including Biostatistics, Statistical Programming, Clinical Operations, Medical, Quality Assurance, Drug Safety and Pharmacovigilance; CROs, central and local laboratories, and other vendors Establish cross-functional, internal data review plans, coordinate data cuts/transfers, and conduct data reviews Review external vendor data management plans, CRF completion guidelines, edit check specifications, external data transfer specifications and other study documentation Represent data management and effectively communicate requirements, strategy, timelines and deliverables at internal cross-functional team meetings and meetings with external vendors Participate in the drafting and/or review of timelines consistent with company goals and ensure all deliverables and milestones are met Review clinical protocols/amendments, clinical study reports, statistical analysis plans, etc. Qualifications: BS/BA in scientific discipline with 6 or more years in Clinical Data Management within a pharmaceutical/CRO setting Strong knowledge of eClinical processes, efficient design/build of an EDC data management system and other Clinical Trial/Data Management Systems Knowledge and understanding of regulations and industry-adopted data standards, such as CDISC SDTM and CDASH Experience working with Medidata Rave EDC Experience using standardized medical terminology, including MedDRA and WHODrug Experience working with MS Office Suite (Excel, Word and PowerPoint) and familiarity with MS Project 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 IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities. https://jobs.iqvia.com/eoe IQVIA’s ability to operate and provide certain services to customers and partners necessitates IQVIA and its employees meet specific requirements regarding COVID-19 vaccination status. https://jobs.iqvia.com/covid-19-vaccine-status