(Senior / Advanced) Clinical Study Manager

About this role

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.