Clinical Research Associate Car-t

AstraZeneca

Italy
Fully remote
Car-t cell therapy study management
Ich-gcp international guidelines knowledge
Site qualification and initiation experience
This role offers a pivotal opportunity to channel scientific capabilities and make a positive impact on changing patients' lives through CAR-T Cell Therapy studies

Job Summary

  • This role offers a pivotal opportunity to channel scientific capabilities and make a positive impact on changing patients' lives through CAR-T Cell Therapy studies.
  • The Clinical Research Associate acts as the main contact for study sites, ensuring proper delivery of studies in compliance with AZ Procedural Documents and ICH-GCP guidelines.
  • Candidates will actively participate in Local Study Team meetings, drive site performance, and ensure timely resolution of study-related issues while maintaining inspection-ready status.

Matching Summary

This role offers a pivotal opportunity to channel scientific capabilities and make a positive impact on changing patients' lives through CAR-T Cell Therapy studies.

Skills & Requirements

Must-have

  • CAR-T Cell Therapy study management
  • ICH-GCP international guidelines knowledge
  • Site qualification and initiation experience
  • Source Data Verification and review skills
  • Risk Based Quality Management principles

Nice-to-have

  • Project management scope and budget skills
  • Experience with external service providers
  • Championing efficient methods and processes
  • Strong negotiation and problem-solving abilities
  • Collaboration with local MSL teams

Key Requirements

  • Scientific degree equivalent
  • Experience managing CAR-T Cell Therapy studies
  • Valid driving license required
  • Excellent knowledge of ICH-GCP guidelines
  • Basic knowledge of GMP/GDP regulations

Work Rights

Not specified

Tailored Resume

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