The GDM will perform scientific (complex) clinical data review in close collaboration with the Study Responsible Physicians (SRP) and Study Responsible Scientists (SRS).
We are looking for a data management expert who has prior experience in performing scientific (complex) clinical data review in close collaboration with the SRP and SRS for at least 1+ years.
Prior experience of closely collaborating with the SRP, SRS, Data Management functions, and other study team members when implementing data management related activities for protocols, with a focus on more complex indication and therapy related elements of the study.
Has prior experience of being involved and driving discussions with SRP/SRS and collaborates with the Data Management team to establish, align, and confirm scientific clinical data review expectations for assigned trial(s).
Takes a leadership role in creating, planning, and tracking content, format, quality, and timing of data management deliverables, including, but not limited to, CRF, data review plan, QC plan, oversight plan, database release plan, final datasets, submission plan, and archival.
Creates clinical data management documents (including submission package) ensuring appropriate quality, scientific content, organization, clarity, accuracy, format, and consistency.
Ensures compliance with regulatory guidelines.
Extensive prior experience of 4+ years supporting studies within the therapeutic area of Oncology or CV&M.
Education/Experience BS/BA degree or higher preferably in Health Sciences, or BS/BA degree or higher with professional clinical experience/exposure.4 years of Data Management experience, preferably including clinical data review or significant experience with clinical data review. Knowledge in medical terminology would be preferable.Collaboration with Clinical teams.Rave knowledge and experience mandatory.This role is not eligible for UK visa sponsorship. 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
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