Clinical Trial Support

• Collaborate with Clinical Science, Clinical Operations, Therapy Development, and Field Clinical teams across Europe, North America, and Asia-Pacific to support timely patient screening and enrollment activities.
• Participate in multidisciplinary case review discussions, screening conferences, and physician review meetings.
• Prepare and present patient imaging analyses during screening conferences and physician case planning sessions.
• Support protocol compliance and consistency in imaging review processes across participating global clinical sites.
• Contribute to the development, refinement, and standardization of imaging review workflows and best practices.

Physician & Site Collaboration

• Serve as a clinical imaging resource for investigators, physicians, study coordinators, and site personnel regarding imaging requirements and screening processes.
• Partner with physicians and Field Clinical Specialists to facilitate patient-specific procedural planning discussions.
• Communicate imaging findings clearly and effectively to both internal and external stakeholders.
• Assist clinical sites in obtaining complete, high-quality CT imaging submissions.

Quality & Compliance

• Ensure all activities are performed in accordance with applicable global regulatory requirements, ICH-GCP guidelines, company policies, and quality system requirements.
• Maintain patient confidentiality and data privacy in accordance with GDPR, applicable local privacy regulations, and study requirements.
• Support audit readiness, inspection preparedness, and documentation compliance.
• Participate in continuous improvement initiatives related to imaging review, patient screening, and clinical operations.

Required Qualifications

• Bachelor's degree required.
• Minimum 3 years of experience supporting structural heart or cardiovascular imaging.
• Demonstrated experience performing advanced TAVR CT analysis using 3Mensio or equivalent imaging software.
• Experience reviewing cardiac CT imaging and supporting TAVR patient evaluation and procedural planning.
• Strong understanding of structural heart anatomy, cardiac CT imaging principles, and transcatheter valve therapies.
• Experience supporting clinical research, medical device companies, or hospital-based structural heart programs.
• Strong organizational skills with exceptional attention to detail.
• Excellent written and verbal communication skills.
• Ability to work independently in a remote environment while collaborating effectively across geographically dispersed global teams.
• Fluent in English (written and spoken) is required. Professional proficiency in German is strongly preferred; additional European languages are considered an asset.
• Proficiency with Microsoft Office applications, including PowerPoint, Word, Outlook, and Teams.
• Willingness and ability to travel internationally up to approximately 10%.

Preferred Qualifications

• Certification in a relevant cardiac imaging modality (ARRT, RDCS, RCS, or equivalent).
• Five or more years of structural heart or cardiovascular imaging experience.
• Prior experience supporting structural heart clinical trials.
• Experience participating in multidisciplinary Heart Team discussions.
• Experience supporting multinational or European clinical studies.
• Knowledge of ICH-GCP, European MDR, FDA clinical trial requirements, and global clinical research regulations.
• Previous experience working within a medical device company developing Class III cardiovascular technologies.

Key Competencies

• Cardiac CT imaging expertise
• Structural heart and TAVR knowledge
• Clinical judgment and patient assessment
• Attention to detail and data accuracy
• Cross-functional collaboration
• Written and verbal communication
• Critical thinking and problem solving
• Organization and prioritization
• Adaptability in a global environment
• Commitment to quality and compliance

Originally posted on Himalayas