Edwards Lifesciences Assoc Mgr, Cln Res Monitoring in Guyancourt, France
Ensure clinical trials are conducted and reported in accordance with all applicable regulatory requirements
• Plan clinical research projects and study conduct activities with accountability for successful completion within scope of project deliverables
• Provide direction and guidance to smaller project teams to execute tactical clinical research projects and/or initiatives. Work with cross-functional team (e.g., clinical data management, field teams) with query management, data reviews and resolution.
• Identify and evaluate process improvements and/or course correction/course alignment opportunities.
Lead in the investigation of all discrepancies in study documentation, by applying clinical protocol knowledge and GCP and develop processes to mitigate reoccurrence throughout study phases
• Conduct in-house and site (if applicable) reviews of associated documentation and lead in internal and competent authority (e.g., FDA, DEKRA, PMDA) audits to ensure documents are compliant with Good Documentation Practices and Edwards internal SOPs, and US and OUS regulations
• Partner with clinical project manager in leading regular team meetings
• Other incidental duties
Education and Experience:
Bachelor's Degree or Equivalent in in related field, 5 years experience of previous related experience Required
• Proven successful project management skills
• Proven expertise in Microsoft Office Suite, including advanced Excel and systems
• Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives
• Extensive knowledge of own area within the organization while contributing to the development of new concepts, techniques, and standards
• Extensive understanding of related aspects of clinical research processes and/or systems
• Strict attention to detail
• Ability to interact professionally with all organizational levels
• Ability to manage competing priorities in a fast paced environment
• Ability to represent leadership on sections of projects within a specific area interfacing with project managers and team
• Ability to consult in a project setting within specific sections of area
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 15,000 individuals worldwide.
For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.