Clinical Data Manager

Supports Clinical Data Manager (CDM) for assigned studies with the planning, execution and management of clinical trials. The CDA is responsible for the following activities with CDM support/oversight:

• Supports Sr.CDM with Data Management activities, including oversight of outsourced activities to CRO and other third-party vendors
• Supporting Sr.CDM in collection, tracking, and maintenance of data management documentation for the electronic Trial Master File (eTMF).
• Accountable for the data quality and data integrity for pivotal clinical studies. Performs periodic review of clinical data coming from EDC and external vendors, run/review data reconciliation checks.
• Maintain study trackers to collect internal study team findings for data discrepancies and coding related queries.
• Assists in the creation/review of data management documents including but not limited to data management plan, database specifications, data validation (edit checks) specifications, report specifications and other functional specifications.
• Create User Acceptance Test (UAT) Plans, Test Scripts and execute testing for EDC setup. Lead and assign user accepting testing to data management peers and oversee the completion of the testing under the oversight of Sr.CDM.
• Execute assigned QC/QA procedures to ensure that clinical databases meet corporate and regulatory standards with accuracy and completeness.
• Oversee data collection processes to ensure accuracy and completeness. Perform data cleaning, validation, and discrepancy management. Implement and monitor quality control measures.