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Clinical Research Associate, Medical Technology & Diagnostics (80-100%)

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 extension) based in Zug area, Switzerland.

Max. 40% home office possible. 25-30% travelling within Europe.

The Clinical Research Associate will design, plan, coordinate, and conduct all activities involved in initiating, monitoring, and completing clinical research studies for in vitro diagnostics.

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
  • Being 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 client’s policies and procedures

Qualifications and Experience:

  • Relevant working/residency permit or Swiss/EU-Citizenship required
  • Bachelor’s degree (Masters and PhD also ok) in science or relevant field, Medical technology degree preferred, but not required if R&D background is adequate
  • Preferably experience in clinical research or laboratory research
  • Min. 2 years of prior relevant experience
  • Basic knowledge of, and skill in applying, applicable clinical research regulatory requirements (i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines)
  • Excellent oral and written communication skills in English
  • Excellent planning, organizing, and interpersonal skills
  • Ability to work independently, make sound decisions, and to analyze and solve problems
  • Medical laboratory experience preferred
  • Good therapeutic and protocol knowledge.
  • Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer and iPhone and iPad (where applicable)
  • Organizational and problem-solving skills
  • Effective time and financial management skills
  • Ability to establish and maintain effective working relationships with coworkers, managers, and clients

Nice to Have:

  • Experience in pathology

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