ISS AG, Integrated Scientific Services, is a service company for the medical device and IVD industry. We are a team of over 40 engineers, scientists and physicians and advise and support our customers from the development to the international market launch of medical devices and IVD. We work with a high standard of professionalism, quality and science. For our CRO department, which is currently being expanded, we are looking for a
Clinical Study Manager (70-100%) (m/f)
- 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.
- 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.
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