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 December 31st
- Flexible working hours as well as hybrid work model within Germany
- Bike leasing via cooperation partner "BikeLeasing"
- Parking garage and safe underground bike storage
- Award-winning subsidized company restaurant and in-house cafes
- Variety-rich fitness program in our ultra-modern 360m2 company gym
- Regular after work, team, and company events
- Comprehensive training and continuing education opportunities
Ready to apply? We look forward to receiving your online application including your first available start date and desired salary.
Contact person: Elisabeth Karro