Clinical Project StartUp Specialist fully remote

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  • Praha
  • Trvalý pracovní poměr
  • Plný úvazek
  • Před 3 dny
Popis poziceWe 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
Požadavky
  • 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
Benefity
  • 5 weeks of paid holiday
  • Possibility to work anywhere from Czech Republic
  • Meal vouchers
  • Cafeteria
  • Mutlisport card
  • Contribution to pension insurance
  • Transport allowance
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