A

Clinical Trial Manager

icon building Unternehmen : Ambu A/S
icon briefcase Auftragstyp : Vollzeit

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Arbeitsbeschreibung - Clinical Trial Manager


Clinical Trial Manager


About the role


At Ambu, we are advancing the future of endoscopy through data-driven innovation. As part of our newly established Clinical Data Acquisition team, you will play a key role in supporting the development of our Endointelligence solutions. 


In this role, your focus goes beyond traditional clinical trials. You will be responsible for ensuring efficient, high-quality collection of clinical data to support the development of AI-based solutions that enhance clinical decision-making. 


You will work closely with colleagues across the organization—from R&D and software teams to Clinical and Commercial—ensuring that data is generated in a way that meets both operational and business needs. As part of a small, growing team, you will have a real opportunity to shape how we work and contribute to building new processes and approaches.. 


 


This is a hands-on and hybrid role, combining clinical trial management with on-site activities and stakeholder coordination. You will be involved across the full study lifecycle, from site identification and setup to execution and close-out, while also collaborating with external partners such as CROs where relevant. 


The position is based at our Innovation site in Augsburg, Germany, with a hybrid working model requiring approximately three days of on-site presence per week, reflecting the importance of close collaboration with the team. 


 


Key responsibilities 



  • Manage clinical studies in accordance with ISO 14155 



  • Contribute to and support protocol development and study design 



  • Identify, initiate, and manage clinical sites across Europe 



  • Conduct and oversee site monitoring activities (directly and via CROs) 



  • Act as a key interface between sites, internal teams, and external partners 



  • Support contracts, budgets, and site agreements in collaboration with internal stakeholders 



  • Monitor and follow up on site performance and recruitment 



  • Contribute to SOP development and optimization 



  • Ensure compliance with regulatory and quality requirements 



  • Participate in audits and inspections as needed 


 


Skills and experiences can be gained in many different ways, and we understand that the best fit for the role cannot be prescribed on paper. You are however likely to succeed in this position if you bring solid experience from clinical operations and enjoy working close to the action, with both sites and stakeholders. 


Your profile 


 



  • Relevant scientific or healthcare degree 



  • Several years of hands-on experience in clinical trials, ideally within medical devices 



  • Strong understanding of ISO 14155 (GCP for medical devices) 



  • Experience in site management, monitoring, and study coordination 



  • Exposure to protocol development and/or regulatory submissions is a plus 



  • CRO experience (as sponsor or vendor side) is highly relevant 



  • Fluent in English and German is a strong advantage 


 


Who you are 


You are someone who enjoys navigating complexity and finding practical solutions. 


You: 



  • Take a pragmatic and solution-oriented approach within regulatory frameworks 



  • Are comfortable working hands-on while keeping the bigger picture in mind 



  • Build strong relationships with sites and stakeholders, understanding different needs 



  • Collaborate effectively across functions and cultures 



  • Are motivated by delivering high-quality results  


 


What you can expect 


You will join a highly supportive and international team, collaborating closely across functions and countries, and where you can have a real impact from day one. This role offers the opportunity to: 



  • Help shape a new and growing function within Ambu 



  • Work at the intersection of clinical operations, innovation, and AI 



  • Gain exposure across a wide range of stakeholders and projects 



  • Develop your career further within Clinical Affairs or broader organizational roles 


 


If you are motivated by building something new, working hands-on with clinical data, and contributing to innovative solutions in healthcare, we would love to hear from you. 


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