Edwards Lifesciences (501+ Employees, 19% 2 Yr Employee Growth Rate)
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, 8 years years experience of previous related experience Required
Experience working in a large manufacturing company Preferred
• 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
• 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 France?
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 France also offers the following benefits:
- Competitive Compensation and Benefits package
- Flexible working hours, remote working
- Profit sharing
- Risk Life Insurance
- Comprehensive Medical plan (including online access to healthcare)
- Service Awards
- Works Council social and cultural activities
- Enhanced Leave Benefits
- Employee Stock Purchase Program
- Employee Assistance Program
Comprehensive Wellness Program including onsite gym, Yoga, Pilates or SM System classes, massages, fresh fruit in the office, healthy lifestyle workshops, 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.