In-House CRA

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 In-House Clinical Research Associate (CRA), you will ensure that clinical trials are conducted and reported in accordance with all applicable regulatory requirements.

How you’ll make an impact:

• Perform study start-up and conduct activities including ICF review to ensure compliance with regulatory requirements

• Create study-specific essential document lists and manage study progress by communicating the status of activities to relevant stakeholders

• Identify and investigate discrepancies in study documentation by applying clinical protocol knowledge, GCP, and ISO14155 guidelines, and develop processes to prevent recurrence throughout all study phases

• Conduct in-house and (if applicable) on-site reviews of clinical documentation and participate in internal and competent authority audits to ensure Trial Master File (TMF) documents are compliant with Good Documentation Practices, Edwards SOPs, and global regulatory requirements

• Support the study team in interactions with Ethics Committees and Competent Authorities

• Participate in project team meetings, as required

• Assess current processes, identify opportunities for improvement, and propose solutions to enhance efficiency within and across related functional areas

• Partner with cross-functional teams (e.g., clinical data management, field teams) on query management, data review, and resolution

• Report on site enrollment progress, including device accountability and protocol deviations (e.g., inclusion/exclusion criteria, sequential enrollment)

• Perform other incidental duties as assigned by management

What you'll need (Required):

• Bachelor’s degree in a related field

• Minimum of 3 years of experience in clinical research (site management, clinical project management, monitoring, and/or as a CRC)

• Experience with quality assurance/control and regulatory compliance or field monitoring in the healthcare industry

• Experience working in a medical device or regulated industry (preferred)

• Experience with electronic data capture systems (required)

What else we look for (Preferred):

• Proficiency in MS Office Suite and clinical systems such as CTMS (Clinical Trial Management System) and eTMF (electronic Trial Master File)

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

• Good problem-solving and critical thinking abilities

• Strong understanding of cardiovascular anatomy, pathology, and physiology

• Moderate knowledge of domestic/international medical device regulatory guidelines relevant to clinical protocols

• Understanding of regulatory submissions, reporting, and audit processes

• Ability to manage confidential information with discretion

• High attention to detail

• Ability to work professionally across all organizational levels

• Strong time management skills with the ability to prioritize tasks in a fast-paced environment

• Comfortable working in team settings, including cross-functional collaboration and representing the organization in specific projects

• Ability to build and maintain effective internal and external working relationships

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  Programme
• Employee  Assistance  Programme
• Comprehensive Wellness  Programme  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.