职位描述

Essential Responsibilities • Development and coordination of research data management plans, including design and create CRFs/EDC for studies, in compliance with company procedures and China medical device regulations. • Partner with Research Manager, Biostatistician and Medical Directors to ensure data is managed appropriately and documented in a manner to facilitate clinical analysis throughout the study and within the study reports. • Manage short and long term tools for data repositories and data queries. • Leads selection and control of external research study data management suppliers. • Maintain and improve procedures to ensure industry standards and regulatory requirements for research data management activities. • Develop and conduct training related to research data management. • Contribute to the Clinical Affairs Operations team and ensure effective collaboration between Clinical Affairs, Medical Affairs, Regulatory Affairs, Legal and Research Managers. About Us GE is the world's Digital Industrial Company, transforming industry with software-defined machines and solutions that are connected, responsive and predictive. Through our people, leadership development, services, technology and scale, GE delivers better outcomes for global customers by speaking the language of industry. Role Summary/Purpose Activities contributing to the design and development of products and their interaction with the human body.Comprehensive in-depth understanding of complex and highly technical concepts and principles in the own part of the function. Strong knowledge of technical concepts in technologies that intersect with own technical space. Qualifications/Requirements Quality Specific Goals: Aware of and comply with Good Clinical Practice guidelines, the GEHC Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position 1. Complete all planned Quality & Compliance training within the defined deadlines 2. Identify and report any quality or compliance concerns and take immediate corrective action as required 3. Ensure Research is executed in compliance with Good Clinical Practices and other applicable regulations and company procedures. 4. Assist with continuous improvement activities by driving the implementation of process improvement initiatives Qualifications/Requirements Qualifications: • Bachelor’s degree (or internationally recognized equivalent) in a science or statistical related field with a minimum of 3 years experience with data management activities within the healthcare industry OR minimum of 7 years progressive experience with research data management in the healthcare, medical device, biologics, or pharmaceutical industry. • Extensive database design, electronic data capture and data query resolution. • Strong experience with Data Management tools. • Good working knowledge of clinical research and regulatory requirements. • Knowledge of Quality Management Systems (QMS) requirements. • Excellent verbal and written communication and presentation skills with the ability to communicate business issues in English in an easy to understand manner. • Demonstrated project management skills to prioritize, plan, delegate & evaluate deliverables; well organized and structured, attention to detail. • Strong problem solving, influencing and negotiation skills. • Proven experience of effective decision making • Demonstrated experience prioritizing conflicting demands from multiple business entities in an extremely fast paced environment. • Ability to work well independently & in a team setting. • Experience with working across cultures/countries/sites• Prior experience using spreadsheet and presentation software. • Must be willing to travel up to 5% of time. Desired Characteristics • Advanced degree in scientific or technology disciplines. • Working programming knowledge from analytical tools including SAS statistical software • Strong knowledge of applicable medical device industry regulations and directives. • Experience interfacing with Regulatory Agencies such as CFDA. • Demonstrated understanding of healthcare environment and knowledge of current competitive, commercial or political situations and their impact on GEHC strategies. 职能类别： 其他

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