Clinical Trial Manager

vor 4 Wochen

Erlangen, Bayern, Deutschland Siemens Healthineers AG Vollzeit
Strengthen Our Product Development Process

Siemens Healthineers AG is seeking a highly skilled Clinical Trial and Customer Use Test Manager to join our team in the Magnetic Resonance (MR) department. As a key member of our global team, you will play a crucial role in planning, organizing, and executing clinical trials and customer use tests to ensure the quality and safety of our products.

Your Key Responsibilities:
  • Plan, organize, and execute clinical trials, including submission to the ethics committee and the Federal Institute for Drugs and Medical Devices (BfArM)
  • Ensure the clinical monitoring of clinical trials in accordance with the Medical Device Regulation (MDR) to guarantee high-quality studies
  • Develop and implement the Customer Use Test (CUT) process in the MR department, including the acquisition of customer feedback from selected customers before product release
  • Lead self-managed, temporary CUT teams within the Business Line and collaborate with international CUT teams
  • Contribute to the design and adaptation of CUT and support contracts in collaboration with other business or organizational units regarding legal requirements, compliance, remuneration, and taxation
  • Analyze customer complaints and derive improvement suggestions
  • Drive the creation, selection, integration, and adaptation of tools for CUT and ECS
Your Qualifications and Experience:
  • You hold a degree in a technical-natural scientific or human scientific field
  • You have several years of experience in diagnostic imaging with interfaces to R&D, product definition, quality, and marketing
  • You have extensive, long-term experience and further qualifications in this field, but no degree? We welcome your application just the same
  • You have good knowledge of product development processes, e.g., in the MR field
  • You have solid knowledge of IT systems, particularly TFS Defect Management (Team Foundation Server) and SAP EDM
  • You have ideal knowledge of regulatory requirements for clinical trials (ethics committee, BfArM, DIMDI)
  • You have already acquired comprehensive knowledge of the open-source management system Open Clinica and its use in clinical studies, administrative knowledge is desirable

Join Our Global Team

Siemens Healthineers is a leading medical technology company with over 75,000 employees worldwide. We are shaping the future of healthcare and improving the lives of millions of patients every day. Our culture values diverse perspectives, open discussions, and the willingness to challenge conventions. We are constantly driving change and innovation in our industry. We invite you to join our team and take on new challenges, test your ideas, and celebrate your successes.

Our Values

We value diversity and equal opportunities and welcome applications from people with diverse backgrounds and, in particular, from people with disabilities.

Get in Touch

Would you like to learn more and clarify any questions personally? Please contact us at +49 9131 18-1717. The contact person for this job posting is Antonia Hanke.

We take the protection of your data and the observance of the GDPR and other data protection regulations seriously. Therefore, we ask you not to send us your resume by email. Please create a profile in our Talent Community to upload your resume. This way, we recognize that you are interested in career opportunities with us and can notify you about relevant job openings. Click here to create a profile.

Siemens Healthineers Deutschland

Siemens Healthineers Deutschland has been awarded the Great Place to Work certificate.

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