Job Description

Responsibilities

  • Coordinate the preparation and submission of clinical trial applications to national regulatory
  • Maintain accurate tracking of submission timelines and approval statuses within the clinical trial management system (CTMS).
  • Serve as the primary point of contact for investigative sites during the initiation phase, providing guidance on regulatory requirements.
  • Ensure the electronic trial master file (eTMF) is complete and compliant with ICH-GCP standards prior to site activation.
  • Site monitoring / Site initiation

Qualifications

  • Min 2 years of experience in clinical trial submissions
  • Fluent German and English

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