Senior Clinical Specialist

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.