Study Start-up Manager (m/w/d) Cell Therapy

AstraZeneca

Hamburg, Germany
Hybrid
Eu-ctr submissions
Ethics committee submissions
Etmf document upload
Prepare high-quality EU-CTR submissions for clinical studies in the start-up phase and conduct submissions to ethics committees and authorities

Job Summary

  • Prepare high-quality EU-CTR submissions for clinical studies in the start-up phase and conduct submissions to ethics committees and authorities.
  • Coordinate and support the processing of RFIs, maintain and update the CTMS with study center data during the start-up phase, and proactively take on tasks within the Submission Expert Group.
  • AstraZeneca offers individual development opportunities, lifelong learning, trust, appreciation, and space for co-creation in a focused, passionate team within a diverse, inclusive, and sustainable work environment.

Matching Summary

Prepare high-quality EU-CTR submissions for clinical studies in the start-up phase and conduct submissions to ethics committees and authorities.

Skills & Requirements

Must-have

  • EU-CTR submissions
  • Ethics committee submissions
  • eTMF document upload
  • CTMS data updates
  • Submission Expert Group tasks

Nice-to-have

  • Innovative products
  • Individual development
  • Diverse and inclusive environment
  • Sustainable company practices

Key Requirements

  • Life Sciences degree or equivalent
  • Experience with CTIS submissions
  • Experience with RFI processing
  • Independent and structured work style
  • Team player with strong communication
  • High assertiveness
  • Fluent German and English
  • Proficient in MS Office

Work Rights

Not specified

Tailored Resume

Cover Letter