Clinical Project Start-Up Specialist | fully remote

Náplň práce

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

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

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