Senior Clinical Data Manager

4 days ago


Lexington, Kentucky, United States Katalyst Healthcares & Life Sciences Full time
Job Title: Senior Clinical Data Manager

Katalyst Healthcares & Life Sciences is seeking a highly skilled Senior Clinical Data Manager to join our team. As a key member of our Clinical Data Management team, you will be responsible for ensuring the quality and integrity of clinical data from study start-up to close-out.

Responsibilities:
  • Data Management: Develop and implement data management strategies to ensure data quality and integrity.
  • Data Cleaning: Lead data cleaning efforts to ensure data accuracy and completeness.
  • Collaboration: Work closely with cross-functional teams, including Data Management, Biostatistics, and Clinical Operations, to develop standard operating processes.
  • Communication: Represent Data Management in study team meetings and provide data status metrics and guidance on data management issues.
  • Documentation: Author Data Management documentation, including Data Management Plans, Data Review Guidelines, and eCRF Completion Guidelines.
  • Training: Develop and deliver Data Management training materials for Investigator Meetings, in-house personnel, and site staff.
  • Project Management: Manage Data Management project documentation, including vendor files, in an audit-ready manner.
  • Data Review: Lead and perform regular data review across studies to identify quality issues, data trends/outliers, and generate queries as necessary.
  • EDC User Management: Manage EDC User Access for all assigned studies.
  • Collaboration: Provide ongoing day-to-day support to Clinical Study Teams to ensure all data is reviewed and discrepancies are resolved.
Requirements:
  • Education: Bachelor's degree or higher in a biological science, nursing, or other health-related discipline.
  • Experience: Minimum of 8 years of experience working in clinical data management, preferably in the pharmaceutical or medical device industry.
  • Skills: Hands-on working knowledge of Electronic Data Capture (EDC) systems, data review and analytics tools, and project management experience.
  • Knowledge: Understanding of clinical trial process, FDA/ICH guidelines, industry/technology standard practices, and Good Clinical Data Management Practices (GCDMP).


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