Regulatory & Site Start-Up Manager | fully remote

Náplň práce

We are looking for a proactive and organized professional to support our client with clinical projects and help manage documentation for clinical sites.
What you will do:
* Prepare and review regulatory documents for clinical sites
* Assist with site contract and budget negotiations
* Support the team in project planning and tracking progress
* Ensure document quality and compliance with GCP standards
* Provide feedback and support to the project team and management
* Participate in site selection and other project activities as needed
Start date: immediately
Contract for limited period with possibility of prolongation

Požadavky

* Degree in a scientific or healthcare field preferred, or a combination of education and relevant experience
* Experience with regulatory submissions in Germany
* Hands-on experience with site contract and budget negotiations
* Solid background in Site Start-Up (SSU) activities and site management
* Fluent in English and German
* Strong organizational and problem-solving skills
* Ability to manage multiple priorities and communicate effectively with different stakeholders
* Knowledge of GCP and clinical research regulations is a plus

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