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