Job Detail

Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 13,000 individuals worldwide.

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.

• 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). Whether as site’s responsible or supervision of CRO/CRA Contractors. Perform co-monitoring visits with CRAs (20%)


• Identify and report adverse events and device-related complications in accordance with regulatory and internal requirementswith the support of the Safety team


• Develop and 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 as well as training and proctoring new employees and/or CRO on trial and study related activities (20%)


• Review monitoring visit reports of CRA’sand 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 (20%)



• Verify trial/study data, including maintaining appropriate regulatory documents both internal (eTMF) and external (ISF), auditing to be sure the site has the appropriate regulatory documentation to conduct the trial/study, and source documentation is properly recorded. Ensure audit readiness for internal and external audits, act as SME/Main support during these audits (20%)




• Act as a mentor to new or junior level employees (5%)




• Contribute to the development of clinical protocols, informed consent forms, and case report forms.   Also contribute to team projects meetings (5%)




• Validate investigational device accountability by tracking the history of investigational devices from Edwards to the field sites and through final disposition (5%)




• Other incidental duties (5%)

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.

• 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). Whether as site’s responsible or supervision of CRO/CRA Contractors. Perform co-monitoring visits with CRAs (20%)


• Identify and report adverse events and device-related complications in accordance with regulatory and internal requirementswith the support of the Safety team


• Develop and 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 as well as training and proctoring new employees and/or CRO on trial and study related activities (20%)


• Review monitoring visit reports of CRA’sand 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 (20%)



• Verify trial/study data, including maintaining appropriate regulatory documents both internal (eTMF) and external (ISF), auditing to be sure the site has the appropriate regulatory documentation to conduct the trial/study, and source documentation is properly recorded. Ensure audit readiness for internal and external audits, act as SME/Main support during these audits (20%)




• Act as a mentor to new or junior level employees (5%)




• Contribute to the development of clinical protocols, informed consent forms, and case report forms.   Also contribute to team projects meetings (5%)




• Validate investigational device accountability by tracking the history of investigational devices from Edwards to the field sites and through final disposition (5%)




• Other incidental duties (5%)