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Clinical Data Management Specialist
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- The QC Data Entry Specialist ensures the accuracy and completeness of patient files by meticulously validating and entering data, utilizing the RealTime CTMS. This role requires a keen understanding of healthcare quality, regulatory standards, and medical terminology, although a clinical research background is not mandatory.
- Conduct a thorough and precise review of study charts utilizing SOPs, policies, GCP, GDP, and sponsor protocols.
- Indicate data points that are missing or discrepant and identify and report any trends to the QC Manager, Team Leads, and upper management.
- Identify and report missing data points or inconsistencies to the clinical research coordinator and QC Manager, Team Leads, and upper management as soon as possible.
- Report any discrepancies between the source and CRF/eCRF immediately to the CRC and the QC Manager, Team Leads, and upper management.
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