Clinical Research Associate, Senior CRA

🔥 8 minutes ago

🌐 Germany, France – Remote

🇩🇪 Germany – Remote 🇫🇷 France – Remote

⏰ Full Time

🟠 Senior

🔬 Research Analyst

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Edwards Lifesciences

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1958

🏥 Healthcare

💼 Consulting

🍽️ Food & Beverage

Healthcare • Consulting • Food & Beverage

Edwards Lifesciences is a global leader in patient-focused medical innovations. The company specializes in heart valve disease solutions, offering products and services such as transcatheter heart valves and mitral and tricuspid technologies, as well as surgical heart valve solutions. Edwards Lifesciences also focuses on critical care technologies including hemodynamic monitoring, remote monitoring, and predictive monitoring. The company conducts clinical research and is committed to improving patient lives through innovative cardiovascular disease solutions, while being a responsible corporate citizen with an emphasis on global corporate giving.

📋 Description

• Conduct clinical monitoring activities at assigned clinical sites across Germany • Serve as key contact for assigned clinical sites throughout the study process • Achieve and report agreed clinical milestones • Support study team interactions with Ethics Committees and Competent Authorities • Participate in project team meetings • Collaborate with internal stakeholders to ensure proper project conduct • Provide site and Edwards personnel training • Prepare and maintain study documents and complete required forms • Report site enrollment progress, device accountability, and protocol deviations • Collect completed Case Report Forms and audit supporting documentation • Process adverse events • Document procedural case observations to investigate post-procedural events • Conduct data review, safety reporting, and complaint handling • Identify and report adverse events and device-related complications according to regulatory and internal requirements • Develop and implement improved processes • Ensure audit readiness for internal, external, and site audits • Perform other incidental duties assigned by management

🎯 Requirements

• Bachelor's Degree in a related field, and/or proven record of strong relevant experience • Previous related medical device and/or clinical experience required • Previous clinical trial site monitoring experience in Germany within a Medical Device or Pharmaceutical setting • Experience with different types of monitoring visits and different study stages • Quality assurance and regulatory compliance experience in a clinical research setting • Driving licence required • Fluency in English and the applicable local language, French or German, is essential • Excellent communication and organizational skills • Expertise in MS Office Suite and ability to operate general office machinery • Good written and verbal communication, presentation, and interpersonal relationship skills • Negotiating and relationship management skills • Problem-solving and critical thinking skills • Ability to adhere to company rules and requirements, including Environmental Health & Safety rules • Cardiology and/or medical device study experience desirable

🏖️ Benefits

• On-the-job development • Training opportunities • Support and guidance from dedicated employee groups • Competitive compensation and benefits package • Comprehensive Wellness Programme • Diverse and inclusive work environment • Opportunities for personal and professional growth