The Senior External Data Specialist ensures electronic vendor data contains all protocol specified parameters, is in correct format, and data populates to the specified fields and patients correctly.
Position is home-based in the US or Canada.
- Develop Data Transfer Agreement and Data Transfer Specifications for vendor data transfers.
- Create Edit checks for all external data types and perform validation.
- Review data discrepancies generated by study specific edit checks for External data and perform the subsequent query management process in resolving the data issues.
- Perform review of the electronically transmitted data for a sample of total number of patients in the study for loading purposes.
- Develop External Data Status Reports, communicate with vendors and participate in Study team meetings.
- Extensive knowledge of Electronic Data Capture (EDC) systems (RAVE, Inform etc.)
- Collect/track local laboratory normal ranges for all sites.
- Edit and perform QC for local laboratory ranges. Verify that normal ranges are properly attached to patient results in the local lab data collection module.
- Attend External Data Kick off meetings as required by sponsor.
- Ensure project deliverables are met for assigned studies.
- Provide guidance and training to team members.
- Perform other duties as required by the department.
- Medical Laboratory Technology certificate preferred/Associates or Bachelor's degree or relevant experience.
- Minimum six (6) years relevant Clinical Data Management experience or an equivalent combination of education and experience to successfully perform the key responsibilities of the job
- Ability to maintain confidentiality of data and information during interactions with staff at all levels
- Demonstrated computer literacy
- Accurate keyboarding skills
- Thorough understanding of medical terminology
- Understanding of ICH-GCP principles
- Demonstrates ability to provide training for EDS levels 1 and 2
- Ability to manage EDS team for larger clients
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