About the Company A fast-growing medical device company specializing in innovative, minimally invasive solutions for structural heart disease. The organization is committed to improving patient outcomes through cutting-edge cardiovascular technologies and fostering a collaborative, purpose-driven culture. With a strong focus on Class III devices and transcatheter therapies, the company offers a dynamic environment for professionals passionate about shaping the future of heart valve interventions. About the Role Senior Clinical Project Manager (sCPM) / Senior Clinical Trial Manager (sCTM) This is a unique opportunity for a hands-on, practically oriented clinical operations leader to join a small but expanding team in Munich, Germany. In this role, you will oversee the full lifecycle of clinical trials, working closely with cross-functional teams to ensure seamless execution and compliance with regulatory standards. Key Responsibilities Clinical Project Management Lead and manage clinical projects from start-up through execution and close-out. Maintain in-depth knowledge of study protocols, therapeutic areas, and indications. Study Documentation & Compliance Contribute to the development and writing of clinical study documentation and SOPs. Ensure study conduct aligns with protocols, ISO-14155, ICH-GCP, MDR, and applicable regulations. Site & Vendor Management Act as the primary point of contact for study sites, ensuring timely resolution of inquiries and protocol compliance. Manage study vendors and oversee deliverables to maintain timelines and quality standards. Data Management & Monitoring Support timely data collection, review, and cleaning to ensure accuracy and resolve discrepancies. Conduct co-monitoring and sponsor visits at study sites as needed. Regulatory Support Prepare and submit study-specific documents to ethics committees and competent authorities. Maintain accurate and up-to-date Trial Master File (TMF) and essential documentation. Cross-Functional Collaboration Work closely with Clinical Affairs leadership and other departments to ensure smooth study execution. Provide regular progress updates and risk mitigation strategies. Requirements Bachelor's degree in Life Sciences, Nursing, or related field. Minimum 4 years of experience in Clinical Trial Management within the medical device industry or CRO, preferably with Class III devices. Proven ability to manage all aspects of clinical trials, including start-up, regulatory obligations, and adverse event reporting. In-depth knowledge of ISO-14155, ICH-GCP, MDR, and associated guidelines. Experience with electronic data capture and tracking systems. Monitoring experience is advantageous. Knowledge of cardiovascular medicine is a plus. Strong organizational skills, attention to detail, and ability to manage multiple priorities independently. Excellent communication skills; proficiency in English required, German is an advantage. Proficiency in Microsoft Office.