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Clinical Data Management Specialist

2 months ago

Markham, Ontario, Canada Everest Clinical Research Services Inc Full time
Job Summary

We are seeking a highly skilled and detail-oriented Clinical Safety Data Associate to join our team at Everest Clinical Research Services Inc. As a key member of our clinical data management team, you will be responsible for ensuring the accuracy and quality of safety data in clinical trials.

Key Responsibilities
  • Develop and maintain safety data review plans and checklists for clinical trial laboratory data, adverse events, and medical events of special interest.
  • Perform safety data reviews according to the review plan and ensure that all issues are resolved in a timely manner.
  • Coordinate with study project managers and clinical data managers to maintain high-quality data collected in clinical trials.
  • Provide medical advice and support to clinical data managers as needed.
  • Code adverse events and medical histories using the MedDRA dictionary and medications using the WHODrug dictionary.
  • Participate in trial protocol review and review of case report forms to ensure accurate and consistent approaches in laboratory data collection.
  • Review and confirm laboratory normal ranges and units from central and local laboratories.
  • Assist clinical data managers in managing local and central laboratory data and resolve related data issues.
  • Contribute to clinical data management initiatives and provide medical and coding support for programming and biostatistics activities as needed.
Requirements
  • RN, M.D., M.Sc., or Ph.D. in Pharmacology or a related field, or equivalent education.
  • Two to three years of experience in clinical trial data management, including medical coding and laboratory data management.
  • Strong knowledge of clinical trial safety data coding and management.
  • Excellent communication and organizational skills, with the ability to work independently and manage multiple projects.