
Specialist, Clinical Research Monitoring
Type
Full time
Location
Job reference
Req-38376
Posted for
2 days ago
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.
Important Notices for Candidates
COVID Vaccination Requirement Notice
Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.
For US Applicants Only
Qualified applications with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers, the California Fair Chance Act, and any other applicable regulation.
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