(Senior / Advanced) Clinical Study Manager

📋 Description

• Independently plan, initiate, manage, and close clinical studies and medical device investigations
• Develop and manage study protocols, timelines, budgets, contracts, site selection, investigator
• Ensure compliance with applicable clinical research regulations, ethical standards, and quality
• Maintain accurate, inspection-ready Trial Master Files (TMF/eTMF) and essential study
• Collaborate with Product Management, R&D, Clinical Marketing, Regulatory Affairs, and other
• Proactively manage study risks, external partners, data quality, and project progress

🎯 Requirements

• University degree in life sciences, biomedical engineering, medicine, or a related scientific
• 5+ years of relevant experience in clinical research, preferably in the medical device industry
• Strong working knowledge of EU MDR (2017/745), including Annex XV, ISO 14155, applicable GCP
• Familiarity with ISO 13485, EU GDPR, relevant MDCG guidance, and clinical research quality
• Hands-on experience with clinical study operations, including TMF/eTMF management, monitoring
• Experience supporting ethics committee and competent authority submissions and maintaining

🎁 Benefits

• 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