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Clinical Research Associate (m/w/d) - Zelltherapie - Region Norddeutschland in Hamburg, Deutschland

AstraZeneca

Hamburg, Deutschland

AstraZeneca seeks a Clinical Research Associate to monitor cell therapy trials across northern Germany. The role involves overseeing study data integrity, site coordination, recruitment performance, and regulatory compliance across all trial phases.

Responsibilities

  • Monitor cell therapy clinical studies and ensure accurate, complete, timely data and document submission across all trial phases
  • Generate high-quality monitoring reports and follow-up letters from site visits
  • Operate study systems (WBDC, IVRS) and maintain CTMS database
  • Initiate study sites, conduct staff training, and provide ongoing site support and guidance
  • Track recruitment performance, site quality metrics, and escalate deficiencies to study leadership

Requirements

  • Completed degree in natural sciences or medicine
  • Demonstrated experience monitoring cell therapy clinical trials (CAR-T, TCR-T, Treg)
  • Excellent ICH-GCP knowledge and understanding of relevant regulations (AMG)
  • Proficiency with electronic Case Report Forms and monitoring reporting systems
  • Fluent German and English language skills
  • Strong analytical, organizational, and communication abilities
  • Willingness to travel with overnight stays

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