Clinical Data Management Professional

5 days ago


London, Greater London, United Kingdom Cytel - EMEA Full time
About the Opportunity

Cytel - EMEA is seeking a dedicated and detail-oriented Clinical Data Management Professional to join our team. As a key member of our team, you will play a critical role in ensuring the quality and integrity of our clinical data.

Key Responsibilities
  1. Develop and maintain coding conventions for specific protocols or programs.
  2. Perform accurate coding of medical terms and medications using industry-wide standards.
  3. Review coded terms for accuracy and consistency and address discrepancies or inconsistencies.
  4. Issue queries in EDC systems to ensure high-quality coding.
  5. Produce coding reports from EDC for team review and utilization.
  6. Perform impact analysis of up-versioning of MedDRA and WHO Drug dictionaries.
Requirements
  • Bachelor's degree in life sciences, computer science, or a related discipline.
  • 1-2 years of progressive hands-on experience in clinical data management (coding group) or clinical research.
  • Proficiency in at least one prevalent coding tool (e.g., Medidata Rave Coder, Merative Zelta Coder).
  • Experience working with clinical trials or within the pharmaceutical environment is preferred.
  • Knowledge of ICH-GCP, local, and international regulations such as 21 CFR Part 11.
  • Proficient in Microsoft Office Suite (Excel, Word, PowerPoint).


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