Clincial Research Associate / Senior CRA

Overview

Innovation starts from the heart. Edwards Lifesciences is the global leader of patient‑focused innovations for structural heart disease and critical care monitoring. With millions of patients served in over 100 countries, each team makes a meaningful contribution by improving patient outcomes and discovering lasting solutions for unmet patient needs.

The Clinical Affairs team is looking for an experienced Clinical Research Associate or Senior CRA (depending on experience) to join our team in Germany. Preferred locations include Munich, Frankfurt, Hamburg, Stuttgart, Cologne, and surrounding areas.

How you will make an impact

• Conduct Clinical Monitoring activities at sites across Germany.
• Serve as key contact to assigned clinical sites throughout the study process.
• Be accountable for achieving and reporting on agreed clinical milestones.
• Support the study team in interactions with Ethics Committees and Competent Authorities.
• Participate actively in project team meetings, as required.
• Collaborate closely with internal stakeholders to ensure proper project conduct.
• Assist in providing site and Edwards personnel training, including preparation/maintenance of study documents and understanding of examinations/assessments required.
• Report site enrollment progress, including device accountability and protocol deviations (inclusion/exclusion criteria, sequential enrollment).
• Collect completed Case Report Forms (CRFs) and confirm and audit supporting documentation.
• Process adverse events.
• Document procedural case observations for insight into post‑procedural events.
• Review data, handle safety reporting and complaints.
• Identify and report adverse events and device‑related complications in accordance with regulatory and internal requirements.
• Develop new improved processes and implement them.
• Ensure audit readiness for internal, external, and site audits.
• Other incidental duties as assigned by management.

What you will need

• 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 in different study stages.
• Knowledge of quality assurance and regulatory compliance in a clinical research setting.
• Driving licence required.
• Fluency in both German and English is essential.

What else we look for

• Excellent communication and organizational skills.
• Proven expertise in MS Office Suite and ability to operate general office machinery.
• Good written and verbal communication skills, presentation and interpersonal relationship skills including negotiation and relationship management.
• Good problem‑solving and critical thinking skills.
• Adherence to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and the implementation of adequate control measures to prevent injuries and protect the environment.
• Cardiology and/or medical device study experience desirable.

Work environment in Germany

As a global leader in patient‑focused medical innovations, we offer rewarding opportunities and exciting challenges in a truly international, dynamic, and friendly work environment. We are committed to fostering a diverse and inclusive workplace where all employees can grow personally and professionally. To support this, we provide on‑the‑job development, training opportunities, and the support of dedicated employee groups (the Edwards Network of Women, Edwards Foundation charity team, sustainability activities, and others).

Benefits

• Competitive Compensation and Benefits package.
• Flexible working hours and remote working options.
• Pension plan.
• Insurance and meal benefits.
• Service awards and enhanced benefits.
• Leave benefits.
• Transportation benefits.
• Employee Stock Purchase Programme.
• Employee Assistance Programme.
• Comprehensive Wellness Programme including onsite gym, yoga classes, massage, preventive health checks, healthy lifestyle webinars, educational events, charity activities, and much more.

Benefits are regulated by an internal policy which contains the full details regarding the entitlement and conditions for the benefits. Benefits policy and components may vary by location.