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

Požadujeme:

• Experience in Site Start-Up (SSU) and site management
• Strong background in German regulatory submissions
• Hands-on experience with contract and budget negotiations
• Fluency in German (C1+) and English (B2+)
• Ability to work independently and manage multiple priorities
• Strong communication and stakeholder management skills

Nice to have:

• Background in clinical research / life sciences
• počet míst - 1

Nabízíme:

• 5 weeks of paid holiday
• Possibility to work anywhere from Czech Republic
• Meal vouchers
• Cafeteria
• Mutlisport card
• Contribution to pension insurance
• Transport allowance