Edwards Lifesciences Mgr, Clinical Project Management in Beijing, China
Provide high quality clinical project planning and execution to meet regulatory and clinical requirements within Asia Pacific and grow the THV business.
• Assist in the development of the clinical plan and monitoring of both manpower and clinical trial budget.
• Assist in managing the implementation and tracking of clinical trial programs from study design, monitoring, follow up and reporting.
• Assist in establishing protocol development, CRF design, project plans and clinical report writings
• Assist in managing CRAs and CROs to ensure timely and quality completion of study and site activities (monitoring, site management, training, study documents, etc.).
• Assist in managing on-site activities including study visits, site selection, site initiation, site management and closeout activities
• 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
• Collaborate as required, with headquarters’ clinical affairs team to support common goals and objectives for the business in the region.
• Assist in development of regulatory and other required study documents for GCP compliance.
• Other duties assigned by Leadership
Education and Experience:
Bachelor's Degree in in related field e.g. Biology, Lifesciences, biostatistics, minimum 8 years years experience of relevant working experience Required
Experienced working in a Multinational company Preferred
• Good medical and technical aptitude and able to demonstrate comprehensive and current knowledge in relevant therapeutic or product areas.
• Experienced working as a CRA and the ability to interact effectively with investigators and cross-functional teams in the pharmaceutical and/or medical device clinical projects.
• Experienced in project management - coordination and planning of budgets, people and time management while being sensitive to time constraints and resource availability.
• Good organizational skills, practical and creative problem analysis and resolution skills.
• Good oral and written communication skills, with ability to communicate and influence effectively at all levels of the organization.
• Good command of English
• Proven expertise in Microsoft Office applications and presentation skills
• Responsible and accountable and have the ability to perform work with minimal supervision and be self-motivated.
• Good ability to manage competing priorities in a fast paced environment
• 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 and proactively escalate issues to appropriate levels of management in the organization
• Ability to manage competing priorities in a fast paced environment
• Represents leadership on sections of projects within a specific area interfacing with project members
• Consult with Business Unit stakeholders, and external vendors
• Adhere to all EHS rules and requirements 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
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.