Senior Clinical Data Management SME
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Job Description
We are seeking a Senior Clinical Data Management SME to provide clinical data leadership across active studies. This role will own clinical data standards, study-level data management planning, data quality planning, SDTM/ADaM mapping oversight, CRO/vendor data onboarding, and translation of clinical study requirements into data pipeline specifications.
The role requires deep experience in clinical data management, CDISC standards, SDTM/ADaM, eCRF design, study protocols, data quality, vendor governance, and clinical data delivery.
Key Responsibilities
*Serve as the primary Clinical Data Management SME across active clinical studies.
*Own and maintain CDISC standards, Clinical Data Management Plans, and Data Quality Plans.
*Own SDTM/ADaM mapping authority across studies and validate domain conformance.
*Review and approve SDTM/ADaM mappings, data quality rules, and study artifacts before release to production.
*G...