(Senior / Advanced) Clinical Study Manager

We are looking for an experienced, proactive, and self-driven (Senior / Advanced) Clinical Study Manager to join our Clinical Affairs team at Brainlab. In this role, you will independently lead clinical studies and medical device investigations from concept to completion, ensuring high-quality execution, regulatory compliance, and timely delivery of clinical evidence. You will collaborate closely with Product Management, R&D, Clinical Marketing, and other stakeholders to translate clinical evidence needs and product roadmap priorities into well-designed and successfully executed studies. Your Responsibilities • Independently plan, initiate, manage, and close clinical studies and medical device investigations, including multicenter and international studies. • Develop and manage study protocols, timelines, budgets, contracts, site selection, investigator relationships, monitoring, data acquisition, data management oversight, and study deliverables. • Ensure compliance with applicable clinical research regulations, ethical standards, and quality requirements. • Maintain accurate, inspection-ready Trial Master Files (TMF/eTMF) and essential study documentation; contribute to the development and improvement of SOPs, work instructions, and clinical research processes. • Collaborate with Product Management, R&D, Clinical Marketing, Regulatory Affairs, and other functions to align clinical evidence generation with product development and business priorities. • Proactively manage study risks, external partners, data quality, and project progress, communicating key milestones and recommendations to stakeholders. • University degree in life sciences, biomedical engineering, medicine, or a related scientific discipline. • 5+ years of relevant experience in clinical research, preferably in the medical device industry, with demonstrated independent management of clinical studies or investigations. • Strong working knowledge of EU MDR (2017/745), including Annex XV, ISO 14155, applicable GCP principles, and relevant European and national clinical investigation requirements. • Familiarity with ISO 13485, EU GDPR, relevant MDCG guidance, and clinical research quality management processes. • Hands-on experience with clinical study operations, including TMF/eTMF management, monitoring, clinical data management oversight, site and vendor management, study budgeting, and clinical study agreements. • Experience supporting ethics committee and competent authority submissions and maintaining inspection-ready documentation. • Strong project management, organizational, communication, and stakeholder management skills. • Demonstrated initiative, accountability, and ability to independently manage complex projects with limited supervision. • Fluent in German and English, written and spoken. Nice to Have • Experience conducting clinical investigations in both Europe and the US, including familiarity with FDA requirements. • Familiarity with clinical evaluation, post-market clinical follow-up (PMCF), and clinical evidence requirements under EU MDR. • Experience in surgical technologies or medical devices related to neurosurgery, spine, orthopedics, ENT, general surgery, or other clinical specialties. • Experience with software as a medical device (SaMD), image-guided surgery, or digital health technologies. • Knowledge of health economics and outcomes research (HEOR), reimbursement pathways, or healthcare coding structures in Europe and/or the US. • Experience supporting scientific publications and dissemination of clinical evidence. • Experience with patient imaging database management. • A mutually-supportive, international team • Meaningful work with a lasting impact on medical technology • 30 vacation days, plus December 24th and