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Fortrea

Senior CRA II Sponsor Dedicated based in Munich, Düsseldorf or Berlin regions

Posted 3 months ago
5-10 years experience
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AI Summary

Act as the primary contact for clinical trial sites, managing the full site lifecycle from start-up to close-out. Ensure study compliance with ICH-GCP and local regulations while overseeing data quality and site performance.

Join Fortrea as a Senior Clinical Research Associate II within a sponsor-dedicated model, where you will work exclusively with a leading global biopharmaceutical partner. In this role, you will support the delivery of high-quality clinical trials across innovative therapies, building strong site relationships and ensuring excellence in study execution.

Working in this model offers close collaboration with the sponsor’s teams, strong study ownership, and the opportunity to contribute directly to advancing cutting-edge treatments for patients worldwide.

Core responsibilities:

  • Act as primary contact for assigned clinical trial sites, building strong, collaborative relationships
  • Manage site lifecycle from start-up through monitoring and close-out, ensuring delivery to timelines and quality standards
  • Conduct on-site and remote monitoring, identifying risks and driving timely issue resolution
  • Ensure compliance with study protocol, ICH-GCP, and local regulatory requirements
  • Oversee site performance including data quality, recruitment, training, and documentation completeness
  • Support study execution (e.g. feasibility, site activation, investigator meetings, audit readiness)
  • Collaborate cross-functionally to implement site strategies and ensure successful trial delivery

Required Qualifications:

  • Bachelor’s degree in Life Sciences or equivalent experience
  • ≥5 years’ experience in clinical research, including site monitoring/site management
  • Proven experience in Oncology, Ophthalmology, Gene Therapy or similar therapeutic area
  • Strong knowledge of ICH-GCP, regulatory requirements, and clinical trial processes
  • Solid problem-solving and critical thinking skills
  • Proficiency in German and in English
  • Willingness to travel
Join Fortrea and take ownership of clinical trial sites across innovative therapies, playing a critical role in delivering high-quality data and accelerating drug development. This role offers strong autonomy, cross-functional collaboration, and exposure to cutting-edge clinical research.
If you are passionate about advancing clinical research and want to grow your expertise in a sponsor-dedicated environment, we encourage you to apply and join us in making a meaningful impact on patients’

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