Edwards Lifesciences is growing and our Specialist, Clinical Research Monitoring position is a unique career opportunity that could be your next step towards an exciting future.  This role will sit within the Endotronix team, who develop implantable heart monitoring technology. Endotronix was acquired by Edwards in July 2024, and will support our future work with heart failure management solutions to address large unmet structural heart patient needs and support sustainable long-term growth. 

For more details on the acquisition, please visit: https://www.edwards.com/newsroom/news/2024-07-24-edwards-lifesciences-expands-structural-heart-port

Support implementation of assigned clinical research projects in Europe related to specific products/topics according to internal and external regional requirements, including acquisition of human use approval from Ethics Committees, case report form review, data collection, site monitoring and auditing. Maintains close contact with clinical study site coordinators and physicians who are clinical investigators.

Key Responsibilities:
• Field monitoring of studies and data collection for clinical trials, assess all data documentation, reports, records, transcripts, exam results for consistency with case report form, and determine if clinical trial/study subject documentation is within parameters of study hypothesis, as well as to monitor clinical trial/study safety, in keeping with protocols, GCP (Good Clinical Practices), and relevant regulatory requirements (e.g. ISO 14155).
• Deliver technical training on GCPs, and relevant regulatory requirements (e.g. ISO 14155), protocols, database, compliance, device accountability, adverse event reporting, study investigation protocols, amendments, regulatory documentation requirements.
• Provide oversight of and insights into trial activities (e.g., trends in protocol compliance, enrollment, monitoring deviations, data quality) to principal investigators and support staff, and study site management including Institutional Review Boards, Contract, and Training, and developing process improvements.
• Verify trial/study data, including maintaining appropriate regulatory documents both internal and external, auditing to be sure the site has the appropriate regulatory documentation to conduct the trial/study, and source documentation is properly recorded.
• Validate investigational device accountability by tracking the history of investigational devices from Edwards to the field sites and through final disposition
• Other incidental duties

Education and Experience:
Bachelor's Degree in a related field

Minimum 3 years years experience with medical device and/or clinical experience Required

Additional Skills:
• 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 negotiating and relationship management skills
• Good problem-solving and critical thinking skills
• Moderate knowledge and understanding of cardiovascular science
• Moderate understanding of cardiovascular anatomy, pathology and physiology
• Moderate understanding of medical device regulatory requirements and documents, device accountability and adverse events reporting
• Ability to manage confidential information with discretion
• Strict attention to detail
• Ability to interact professionally with all organizational levels
• Ability to manage competing priorities in a fast paced environment
• Must be able to work in a team environment, including inter-departmental teams and representing the organization on specific projects
• Ability to build productive internal/external working relationships
• Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control

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.