For their CRO department, which is currently being expanded, ISS is looking for a Clinical Study Manager. 

Description du poste

ISS AG, Integrated Scientific Services, is a service company for the medical device and IVD industry. It provides services to medtech companies for the development of medical devices, their introduction into the market and their maintenance. Typical services include embedded software development, regulatory affairs and clinical evaluation report writing, clinical research, quality management, qualification and validation. The combination of these services with scientific work methods and project management puts ISS AG into a unique position as a service provider for the medtech industry.

For their CRO department, which is currently being expanded, ISS is looking for a Clinical Study Manager. Place of work is Biel (directly at the railway station) and partly home office.

Your tasks

  • You will further expand our service and be part of the targeted growth of ISS CRO.
  • You will act as project manager for clinical trials with medical devices and IVDs and be the central contact person for both clients and team members.
  • You plan, coordinate and monitor clinical studies and are responsible for the professional and qualified cooperation with the client as well as other persons involved in study projects.
  • You will ensure that studies are implemented according to protocol, time and budget and that regulatory requirements are met by obtaining the necessary approvals or consenting assessments from the authorities and ethics committees involved.
  • You will be responsible for the further development of the clinical QMS (ISO 14155:2020) and continuously improve processes, standards and services using best practices and knowledge of internal and external business processes.
  • You are responsible for the audit and inspection readiness of the CRO.
  • You take over CRA activities in Switzerland and the coordination of CRAs in Europe.
  • You provide webinars and courses on study topics.
Contact
ISS AG, Integrated Scientific Services
Dr. Michel Weber, Head of Clinical Services
Tel. 032 513 6780
  • michel.weber@iss-ag.ch

Profil requis

Your profile

  • You have a degree or equivalent training in the healthcare sector.
  • You have experience as a CRA and study manager and have worked in the industry for at least 2 years. Ideally you know the CRO business in Switzerland and Europe.
  • You are familiar with all phases of a clinical trial, planning, organisation, monitoring and supervision.
  • You have excellent project management and communication skills and an independent, thorough approach to work and collaboration. A hands-on mentality is a prerequisite.
  • You are motivated to work in a dynamic environment and are looking for a position in which you can quickly familiarise yourself with new issues and a wide variety of needs of clients.
  • You have a very good command of written and spoken German and English. A good knowledge of French is desirable

What we offer

We offer you an interesting, varied and challenging job in an interdisciplinary team with development opportunities. You can help shape the future of our company and demonstrate your entrepreneurial skills. You will benefit from a flexible working time model and good opportunities for further training. Place of work is Biel (directly at the railway station), partly home office.

Application

If you have any questions, please do not hesitate to contact us or send us your complete application documents by email to the address below.

Offers from recruitment agencies will not be considered.

ISS AG, Integrated Scientific Services
Dr. Michel Weber, Head of Clinical Services
Tel. 032 513 6780, michel.weber@iss-ag.ch 

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