Performs and coordinates all aspects of the clinical monitoring and site management process.
Conducts remote or on-site visits to assess protocol and regulatory compliance and manages required documentation.
Acts as a site processes specialist, ensuring that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations and SOPs.
Ensures audit readiness.
Develops collaborative relationships with investigational sites.
Monitors investigator sites with a risk-based monitoring approach, applying root cause analysis, critical thinking and problem-solving skills to identify site processes failure.

Bachelor's degree in a life sciences related field or equivalent and relevant formal academic / vocational qualification
Previous experience that provides the knowledge, skills, and abilities to perform the job
Valid driver's license
Full Right to work in Germany
Fluency in English and German language to at least C1 level

CRA I/II – Klinischer Monitor

Key skills