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The GDM will perform scientific (complex) clinical data review in close collaboration with the Study Responsible Physicians (SRP) and Study Responsible Scientists (SRS).
Looking out for data management expert, who has prior experience in performing scientific (complex) clinical data review in close collaboration with the Study Responsible Physicians (SRP) and Study Responsible Scientists (SRS) in the past for at least a duration of 1+ years.
Prior experience of closely collaborating with the SRP, SRS, Data Management functions and the rest of the study team members when implementing the data management related activities for protocols, with 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. Ensures
deliverable
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 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 Data management experience. Data Management experience preferably including clinical data review or significant experience with clinical data review. Knowledge in medical terminology would be preferable
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