Clinical Trial Manager (OrphaCare)

We are looking for a Clinical Trail Manager to support the establishment and operation of the company’s medical and clinical research activities related to the development of a Class III medical device for an EMA orphan indication.

• Support development of internal processes and documentation.
• Assist in creation and maintenance of SOPs and templates.
• Clinical Trial Preparation & Coordination
• Support feasibility, site communication, and document preparation.
• Assist in submissions to Competent Authorities and Ethics Committees.
• Regulatory & EMA-Related Support
• Assist in preparing EMA briefing documents and regulatory packages.
• Coordinate collection of input from internal and external experts.
• CRO & Vendor Coordination
• Clinical Operations Support
• Cross-Functional Collaboration
• Work with RA, QA, R&D, Market Access to support clinical development.
• Assist in preparation for audits and inspections.

• 3–5 years of experience in clinical research; experience in medical devices or orphan indications is a strong plus.
• Solid understanding of ISO 14155, MDR 2017/745, and ICH-GCP standards.
• Bachelor’s or Master’s degree in Life Sciences, Biomedical Engineering, Medicine, or a related field.
• Fluency in English (written and spoken); additional languages are an advantage.
• Strong organizational skills, attention to detail, and ability to manage multiple tasks in parallel.
• Excellent communication and cross-functional collaboration abilities.

• Join a high-performing team within an open, collaborative corporate culture that encourages initiative and the contribution of new ideas.
• Benefit from a structured onboarding process and ongoing training opportunities to support your professional development.
• Enjoy a bonus scheme and comprehensive benefits.
• Access continuous personal and professional development opportunities within an international environment.