Many structural heart patients suffer from heart failure with limited options. Our Implantable Heart Failure Management (IHFM) team is at the forefront of addressing these unmet patient needs through pioneering technology that enables early, targeted therapeutic intervention. Our innovative solutions are not just transforming patient care but also creating a unique and exciting environment for our team members. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.

In the role of Clinical Research Monitoring Specialist, you will support implementation of assigned clinical research projects across Europe. Your focus will be on specific products or topics, ensuring full compliance with both internal standards and regional regulatory requirements. You will be involved in obtaining human use approvals from Ethics Committees, reviewing case report forms, data collection, site monitoring and audits. You will also maintain close contact with clinical study site coordinators and physicians acting as clinical investigators.

How you’ll make an impact:

• Field monitoring of clinical studies and data collection for clinical trials. Assess documentation, reports, records, transcripts, and exam results for consistency with case report forms, and confirm that subject documentation aligns with the study hypothesis. Monitor clinical trial/study safety in accordance with protocols, GCP (Good Clinical Practices), and applicable regulatory requirements (e.g., ISO 14155).

• Deliver technical training on GCP, regulatory requirements (e.g., ISO 14155), study protocols, databases, compliance, device accountability, adverse event reporting, investigation protocols, amendments, and regulatory documentation.

• Provide oversight and insights into trial activities (e.g., protocol compliance, enrollment, deviations, data quality) to principal investigators and support staff. Contribute to study site management activities including Institutional Review Board (IRB) coordination, contracts, training, and process improvements.

• Verify trial/study data, maintain internal and external regulatory documentation, and support audits to ensure appropriate trial/study documentation and accurate source data recording.

• Validate investigational device accountability by tracking devices from Edwards to the field sites and through final disposition.

• Other incidental duties.

What you'll need (Required):

• Bachelor's Degree in a related field

• Minimum 3 years years of experience in medical device industry and/or clinical experience
   

What else we look for (Preferred):

• Moderate understanding of cardiovascular science, including anatomy, pathology, and physiology

• Familiarity with medical device regulations, documentation requirements, device accountability, and adverse event reporting

• Strong written and verbal communication skills, including presentation, negotiation, and stakeholder relationship management

• Excellent organizational, problem-solving, and critical thinking abilities

• Ability to manage confidential information with professionalism and discretion

• High attention to detail and accuracy in a fast-paced, deadline-driven environment

• Ability to build productive working relationships across internal and external teams

• Comfortable working cross-functionally and representing the team on project-based initiatives

• Proficiency in Microsoft Office Suite

• Commitment to safety, compliance, and adherence to company protocols (e.g. pandemic guidelines, Environmental Health & Safety standards)

What is  it  like  to work at  Edwards  Lifesciences  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 work environment where all employees can grow, personally and professionally. To achieve this, we offer on-the-job development, training opportunities and the support and guidance provided by dedicated employee groups (the Edwards Network of Women, Edwards Foundation charity team, sustainability activities, and others).  

Edwards  Lifesciences  in  Germany  also  offers  the  following  benefits:

• Competitive  Compensation  and  Benefits  package

• Flexible  working  hours,  remote  working

• Pension  plan Risk  

• Insurance Meal  Benefits  

• Service  Awards Enhanced  

• Leave  Benefits

• Transportation  Benefits

• Employee  Stock  Purchase  Program

• Employee  Assistance  Program

• Comprehensive Wellness  Program  including  onsite  gym,  yoga classes  and  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.