Innovation starts from the heart. Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. With millions of patients served in over 100 countries, each team makes a meaningful contribution by improving patient outcomes and discovering lasting solutions for unmet patient needs. Our Clinical Project Management position is a unique career opportunity that could be your next step towards an exciting future.

Key Responsibilities:

Manage clinical affairs team and activities within the assigned area.
• Manage and oversee the work of small Clinical Affairs team and may indirectly manage cross functional or matrix teams as appropriate. Develop a robust talent development plan in alignment with functional growth strategies of the department.
• Manage on-site activities including study visits, site selection, site initiation, site management and closeout activities
• Manage the implementation and tracking of all clinical trial programs from study design, monitoring, follow up and reporting across the region
• Establish protocol development, CRF design, project plans and clinical report writings. Research and provide technical expert response to deficiency letter questions from the PMDA (Pharma Medical Device Agency)
• Collaborate closely with headquarters’ clinical affairs team to support common goals and objectives for the business in the region
• Develop, review and approve regulatory and other required study documents for GCP compliance. Recommend policies, procedures and processes to ensure high level of quality control and quality assurance
• Communicate with key study investigators regarding the clinical trial related matters. Manage ongoing communication of study operation issues and provide accurate progress reports on assigned activities to study team
• Other incidental duties

Education and Experience:
Bachelor's Degree in in related field (e.g. Biology, Lifesciences, Biostatistics)Experienced working in a Medical Device or Healthcare industry Required
Master's Degree or equivalent Preferred

Additional Skills:

• Excellent ability to read, write and speak English
• Excellent understanding of Clinical Research procedures while addressing issues with impact beyond own team based on knowledge of related disciplines
• Excellent understanding of related aspects of Clinical Research processes and/or systems
• Knowledge of financial mechanism that relates to Clinical Research
• Demonstrated ability to manage assigned team and provide coaching and feedback, including responsibility for all employee actions including hire/fire authority and partnering with HR on all aspects of employee relations
• Ability to develop and integrate metrics into the projects and operations that clearly demonstrate the value of Clinical Affairs to the business
• Strict attention to detail
• Excellent oral and written communication skills, with ability to communicate and influence effectively at all levels of the organization.
• Proven expertise in Microsoft Office applications and presentation skills
• Excellent ability to manage competing priorities in a fast paced environment
• Ability to interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management in the organization
• Ability to work and excel within a fast paced, dynamic, and constantly changing work environment
• Knowledge of Good Clinical Practice
• Frequently interacts with internal and external stakeholders, and/or functional peer group managers, normally involving matters between cross-functional teams and the company; often leads a cooperative effort among members of a project team
• Participate and present at meetings with internal and external representatives
• Develop relationships and leverage them to influence change
• Support and solicit input from team members at all levels within the organization
• 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