Local Regulatory Contact SSU/ Regulatory Lead

vor 23 Stunden

Berlin, Deutschland Link Medical Vollzeit

As LINK Medical continues to grow, we currently have an open position at our office in Berlin (DE)
LINK Medical is searching for a highly motivated Local Regulatory Contact Study Start-Up (SSU)/Regulatory Lead (Clinical Studies)/ (Sr) CRA in Germany. As a Local Regulatory Contact SSU /Regulatory Lead (Clinical Studies), you will work in close collaboration with members of internal and external project teams, with local and international projects, and within a range of different therapeutic areas. This role can also be combined with a CRA role. As a CRA you may also be outsourced to clients, and the position will involve frequent travelling related to monitoring visits.

This includes both medicinal products and medical device studies and interventional as well as non-interventional studies.)
If applicable also work partly as CRA including
Monitor and manage clinical trials (phases I-IV) in compliance with protocol, ICH-GCP/ISO 14155, SOPs, and regulations. Perform Source Data Review (SDR), Source Data Verification (SDV) and review Case Report Forms (CRFs)
Bachelor’s degree or equivalent in a relevant field
Experience in clinical trials submissions for both investigational medicinal products and medical device locally and preferably also internationally incl. Fluent in the local language and English
LINK Medical offers an exciting and challenging position in a European CRO that has a strong local presence. The company focuses on collaboration, sharing of experience and continuous development of our employees in an international environment and values as honest and open communication are essential. Besides a great working environment with dedicated and supporting colleagues, we also offer a competitive compensation, benefit scheme and great development opportunities for all employees.

Elin Nilsson, Director Clinical Project Management

Please submit your application in English.

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