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. This includes closely collaborating with the SRP, SRS, Data Management functions, and the rest of the study team members when implementing data management-related activities for protocols, focusing on complex indication and therapy-related elements of the study.
The candidate should have experience driving discussions with SRP/SRS and collaborating with the Data Management team to establish, align, and confirm scientific clinical data review expectations for assigned trials.
The role involves taking a leadership position 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.
The candidate will create clinical data management documents (including submission packages) ensuring appropriate quality, scientific content, organization, clarity, accuracy, format, and consistency, while ensuring compliance with regulatory guidelines.
Extensive prior experience of 4+ years supporting studies within the therapeutic area of Oncology or CV&M is required.
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 is preferable.
* Experience collaborating with clinical teams.
* Rave knowledge and experience is mandatory.
This role is not eligible for UK visa sponsorship.
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