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Clinical Research Associate, Medical Technology & Diagnostics

Our client is a pioneer in Drug Discovery and Development and one of the frontrunners in Personalised Healthcare. As the world`s largest R&D spender in the pharmaceutical and diagnostics domain, they work in a vast number of drug discovery & therapeutic areas and are highly recognized internationally. 

We are currently looking for a Clinical Research Associate, Medical Technology & Diagnostics for an unlimited contract (12 months initially with planned extensions) based in Zug area, Switzerland.

On-site presence required 2-3 days/week. 25-30% travel.

Main Responsibilities:

Ensuring studies are conducted and documented in accordance with the study protocol, standard operating procedures, good clinical practices and other applicable regulatory requirements

Validating product performance claims

  • Supplying data for critical Regulatory submissions
  • Defining the functional and clinical utility of investigational products
  • Obtaining opinions and input regarding investigational products from laboratories or customers, who may be considered key opinion leaders
  • The CRA is responsible for adhering to the policies of the quality system and achieving quality objectives through daily actions
  • Performing or coordinating aspects of clinical studies including site selection, study initiation, site monitoring, and study closeout
  • Maintaining communication with study investigators to ensure studies are completed in a timely fashion and ensuring that study objectives are met
  • Interfacing with cross functional staff to support post launch activities
  • Reviewing cases with investigators to resolve discrepancies
  • Ensuring that studies adhere to FDA regulations, Good Clinical Practices, IVD directives, and company policies and procedures

Qualifications and Experience:

  • Relevant working/residency permit or Swiss/EU-Citizenship required
  • Minimum Bachelor’s degree required; Master’s or PhD also accepted. Field of Medical Technology, R&D Development
  • 2–5 years’ industry experience (Medical Diagnostics)
  • Preferably experience in clinical research or laboratory research
  • Strong knowledge of GCP, ICH, and IVD guidelines
  • Experience with clinical research regulatory requirements
  • Strong communication and laboratory skills
  • English fluency required

Nice to Have:

  • Technical pathology background
  • Familiarity with FDA and EU regulations is an advantage

Would you like to learn more about CTC and the opportunity outlined? Please, get in contact with us: you may either use the 'apply now' button, or write an email to us, or reach out to us on the phone.

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