We are currently looking for an experienced Regulatory & Site Start-Up Manager to join an international clinical research project focused on the German market.

This is a great opportunity to work on a large-scale study, be part of an experienced global team, and take ownership of key site start-up activities from day one.

Your responsibilities:

• Lead site start-up activities for clinical trials in Germany
• Prepare and submit regulatory documents (including ethics submissions)
• Handle ICF adaptation and approvals
• Negotiate site contracts and budgets
• Support site identification and feasibility
• Ensure timely site activation and maintain study timelines
• Track progress and maintain SSU documentation and systems
• Collaborate with cross-functional teams and provide local regulatory expertise
• Ensure compliance with GCP and clinical research regulations