The Sr. CDM will lead and contribute to data management activities in support of Client's studies across all stages of clinical drug development.

Summary of Key Responsibilities

Contribute to data management activities as a lead study data manager in support of Client's clinical studiesLead database build activities including leading cross-functional review of eCRF content, review of edit check specifications, and perform user acceptance testingMonitor data collection, coding, and cleaning by vendors through tracking of study metrics and targeted data reviewsOversight of database lock activities and ultimate archiving of study dataCollaborate with internal and external partners, including Biostatistics, Statistical Programming, Clinical Operations, Medical, Quality Assurance, Global Patient Safety and Risk Management, and Regulatory Affairs; CROs, central and local laboratories, and other vendorsEstablish cross-functional, internal data review plans, coordinate data cuts/transfers, and conduct data reviewsReview CRO data management plans, CRF completion guidelines, external data transfer specifications and other study documentationContribute to development and implementation of department workflows and infrastructure strategy (such as preferred provider interactions, SOPs, and templates) that reflects data collection standards, consistent with industry best practice and regulationRepresent data management and effectively communicate requirements, strategy, timelines and deliverables at internal cross-functional team meetings and meetings with external vendorsParticipate in the training of external vendors and site staffParticipate in the drafting and/or review of timelines consistent with company goals and ensure all deliverables and milestones are metReview clinical protocols/amendments, clinical study reports, statistical analysis plans, etc.Support GCP inspection readiness

Qualifications

BS/BA in scientific discipline,At least 7 years related experience in a pharmaceutical/biologics/biotechnology companyExperience working in clinical drug development through Phase 3 in an outsourced CRO model; experience with drug development in rare genetic diseases preferredExpert knowledge of eClinical processes, efficient design/build of an EDC data management system and other Clinical Trial/Data Management SystemsKnowledge and understanding of regulations and industry/adopted data standards such as CDISC, SDTM, and CDASHExperience working with Medidata RaveExperience using standardized medical terminology, including MedDRA and WHODrugExperience working with MSOffice Suite (Excel, Word, PowerPoint) and familiarity with MS ProjectExcellent written and oral communications skillsHighly motivated and flexible, with excellent organizational and time management skillsAbility to work independently and as part of a multi-disciplinary teamUnderstanding of ICH GCP as well as general knowledge of industry practices and standardsKnowledge and understanding of regulatory requirements and expectations for clinical data systems including 21 CFR Part 11NDA/MAA experience

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com