Job Overview: EDS Data Lead-Lab Data Position is home-based in the US or Canada.
Main responsibilities: * 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: * 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