JOB DESCRIPTION
Job Overview:
Covance by Labcorp is looking for a Senior Clinical Data Analyst for our FSPx department.
- Ensures electronic vendor data contains all protocol specified parameters, is in correct format, and data populates to the specified fields and patients correctly.
- 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.
Education/Qualifications:
- Medical Laboratory Technology certificate preferred/Associates or Bachelor’s degree or relevant experience.
Experience:
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
