Biologist, Chemist - Clinical Trials, Project Management (m/f/d)

Beschreibung

As a steadily growing international manufacturer of high quality vascular implants, we help surgeons save lives. For this reason, we are looking for committed employees (m/f/d) who will work enthusiastically and ambitiously to find the best possible solution for the patient and the user.

We are seeking a

CLINICAL TRIAL MANAGER m/f/d

What you will be doing:

• Planning and conducting international clinical studies, ensuring study teams deliver on time and quality
• Monitoring CROs and regularly drafting reports on the status of studies
• Regulatory approvals and approvals by ethics committees in Europe and Asia
• Preparing study contracts
• Organising and conducting investigator meetings
• Safety notices and coordination of the clinical evaluation committee (CEC)

What you need to get started:

• Degree in natural sciences, medicine, medical technology or pharmaceutical education
• At least 1-2 years of experience as a Clinical Project Manager (m/f/d) in the planning and implementation of international clinical studies with medical devices in Europe and Asia-Pacific
• Experienced and familiar with medical devices and associated regulations: ISO 14155, MedDev, MDR 2017/745
• Experience with regulatory audits (FDA experience desirable)
• Experience in negotiating study contracts
• Very good knowledge of the relevant national and international regulations
• Excellent organisational and administrative skills
• Motivating and respectful communication internally, with business partners and investigators
• High level of commitment to reach the expected objectives

What you can expect:

• An exciting and steadily growing product portfolio for vascular therapy
• Varied tasks within a dynamic team
• Freedom for ideas and independent work
• Intensive training in areas of responsibility