Join this dynamic team dedicated to revolutionizing patient care with innovative, minimally invasive treatment solutions. We are seeking a proactive and skilled Clinical Trial Manager / Clinical Project Manager to play a vital role in this expanding medical device company based in Munich, Germany. This is a unique opportunity to work closely with the clinical affairs team and contribute to improving patient outcomes.

In this position, you will oversee clinical project management and day-to-day operations throughout the study lifecycle. Your expertise will ensure that our clinical studies adhere to the highest standards while fostering collaboration across cross-functional teams.

Key Responsibilities

• Oversee clinical project management and day-to-day clinical operations throughout the entire study lifecycle, including start-up, execution, and close-out.
• Maintain in-depth knowledge of protocol, therapeutic area, and indication.
• Contribute to the development and writing of clinical study documentation and processes.
• Ensure study conduct aligns with the clinical study protocol and relevant regulations.
• Serve as the primary point of contact for study sites, ensuring prompt resolution of inquiries to maintain protocol compliance.
• Support timely clinical data collection, review, and cleaning activities to ensure high data quality and resolve any discrepancies.
• Responsible for management of study vendors.
• Maintain accurate and up-to-date study documentation and Trial Master File (TMF), including the collection, administration, and tracking of essential documents.
• Support the submission of study-specific documents to regulatory authorities, including ethics committees and competent authorities.
• Conduct co-monitoring and monitoring visits, as well as other sponsor-initiated visits at study sites if required.
• Monitor study progress and provide regular updates to Clinical Affairs leadership.
• Collaborate with cross-functional teams to ensure seamless execution of clinical studies.

Required Qualifications and Skills

• Bachelor’s degree in Life Sciences, Nursing, or a related field.
• Minimum of 4 years of experience in Clinical Trial Management within the medical device industry or a Contract Research Organization (CRO).
• Demonstrated ability to drive clinical trial activities: experience in all aspects of study start-up and conduct, regulatory obligations, adverse event reporting, etc.
• In-depth working knowledge of ISO-14155, ICH-GCP, MDR, and associated guidelines.
• Ability to work independently and manage multiple priorities.
• Experience with electronic data capture and tracking systems.
• Monitoring experience is advantageous.
• Knowledge of cardiovascular medicine is a plus.
• Strong attention to detail, with excellent organizational and teamwork skills.
• Exceptional communication abilities.
• Proficiency in Microsoft Office.
• Proficiency in English is required; German language skills are an advantage.