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The Lead Clinical Data Manager is responsible for ensuring the accuracy, completeness and integrity of data collected during IVD clinical trials. The CDM is responsible for developing the clinical data management plan for pre-market and post-market clinical trials and timely execution of the plans throughout the lifecycle of the study.
This position reports to the Clinical Affairs Manager, Global QRC On-market Sustainment and will be an in office role in Bengaluru, India.
In This Role, You Will Have The Prospect To
Develop clinical study data management plans and provide clinical data management support for clinical teams, study projects, and biostatistics, including execution of data management plans across the full study lifecycle.
Develop case report forms (or eCRF), clinical trial data specifications, EDC database specifications, user requirements, edit rules/checks, query logic and data validations.
Define and/or create data listings, summary table validation, data specifications and/or process data transfers in preparation for statistical review and/or data management audit.
The Essential Requirements Of The Job Include
Bachelor's or master's degree in science or health care area
5+ years of experience in developing and executing clinical data management procedures and thorough knowledge of clinical research.
Experience with executing database lock, freeze, close-out audits and a .
