Clinical Development Manager

vor 4 Wochen


Solothurn, Solothurn, Schweiz Ypsomed Vollzeit

About the Role

Clinical Research Manager needed to oversee global clinical trials, ensuring compliance with ISO, the Declaration of Helsinki, and relevant national laws and regulations.

Key Responsibilities

  • Ensure adherence to clinical trial standards as governed by the Food and Drug Administration (FDA)
  • Supervise and support CROs and trial centers in the preparation and conduct of clinical studies
  • Plan, coordinate, and conduct audits to ensure compliance with GCP guidelines, internal quality standards, and regulatory requirements
  • Establish and maintain relationships with local & international opinion leaders, trial centers, CROs, and other third parties
  • Communicate effectively with internal and external stakeholders, including regulatory authorities, ethics committees, CROs, investigators, and advisors

Requirements

  • Master of Science (MSc) degree in a natural science discipline or in the health sector, or equivalent qualification
  • Doctorate (PhD or Dr.) is an advantage
  • Experience in planning and monitoring clinical trials, with knowledge of ISO, GCP, and FDA regulations
  • Knowledge of clinical research/testing methodology and the medical device industry
  • Fluent in written and spoken English

About Ypsomed

Ypsomed is a successful, rapidly growing, family-owned company that develops and produces injection and infusion systems for self-medication. We enable people worldwide to self-treat chronic diseases, such as diabetes, obesity, or certain types of cancer, with the greatest possible quality of life.



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