(Senior / Advanced) Clinical Study Manager
Brainlab · Munich, BY, Germany · hybrid
At the forefront of health technology for over 35 years, Munich-based Brainlab digitizes medical workflows, from diagnosis to therapy, to offer clinicians and patients better treatment possibilities. Our innovative digital ecosystem forms the basis for modern healthcare technology in 4000 hospitals in 120 countries.
Our key to success is our creative, talented and hard-working team, which consists of around 2000 dedicated and inspiring individuals in 25 locations worldwide. To succeed in reaching our targets, we are seeking committed colleagues who can stand behind our core values curious, authentic and useful.
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