The Life Science Career NetworkCTC are specialised industry experts who can help companies source the best talent and provide reliable HR and consulting services, support varied candidates in finding promising career opportunities and offer the latest in skill development training programmes.Clinical Research Associate, Medical Technology & DiagnosticsOur 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 1-3 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 requirementsValidating 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)
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
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