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Clinical Data Manager

$10/hr Starting at $25

A spectrum of working experience in end-to-end clinical data management and in various phases of study set up(start-up), conduct, and closeout

  • Review the clinical data and identify the discrepancies using an electronic database or through a manual review process.
  • Experience in Data review and query Management of Paper study.
  • Generate the Data Clarification Form (DCF) / query on discrepancy data and get the resolution from clinical investigative staff.
  • Perform Data quality checks and document the process.
  • Handle external data e.g., Lab(Local and Central), imaging,  Pk reconciliation, and perform the data reconciliation process and resolve the data issues pertaining to the external data.
  • Perform Serious Adverse Event (SAE) reconciliation and resolve the query pertaining to the SAEs.
  • Perform medical coding using MedDRA, and WHO Drug as applicable, and maintain the dictionary files and versions

About

$10/hr Ongoing

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A spectrum of working experience in end-to-end clinical data management and in various phases of study set up(start-up), conduct, and closeout

  • Review the clinical data and identify the discrepancies using an electronic database or through a manual review process.
  • Experience in Data review and query Management of Paper study.
  • Generate the Data Clarification Form (DCF) / query on discrepancy data and get the resolution from clinical investigative staff.
  • Perform Data quality checks and document the process.
  • Handle external data e.g., Lab(Local and Central), imaging,  Pk reconciliation, and perform the data reconciliation process and resolve the data issues pertaining to the external data.
  • Perform Serious Adverse Event (SAE) reconciliation and resolve the query pertaining to the SAEs.
  • Perform medical coding using MedDRA, and WHO Drug as applicable, and maintain the dictionary files and versions

Skills & Expertise

Clinical Data ManagementData ManagementData ValidationDatabase DevelopmentManagementQuality Assurance

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