The Estee Lauder Companies CN.研发.临床实验..高级临床研究员 in 上海, China
Reinforce ELC clinical capabilities in Asia. Perform clinical studies in Asia to support claims and formula development. Work closely with the Global Clinical team to coordinate the fielding of studies in Asia. Assure quality and data integrity in the execution of clinical studies. This position is primarily responsible for working with ELC approved clinical labs in Asia and coordinating the clinical testing for claims or innovation proof of concepts in accordance with Good Clinical Practices and company's SOPs. This position works closely with the Global Clinical team to field studies in Asia to fulfill claim support needs. This position's responsibilities review protocols, study report forms, informed consents and reports as needed; work the CRO to finalize study reports, perform data analysis, statistics.
Function as a clinical sponsor for studies performed at CROs in Asia. Assures that the protocols are accurate and fully supporting the established clinical plans with the appropriate parameters tested, timepoints included, methods applied, and studies performed in accordance with GCP and company's SOPs. Help develop the network of external partners, focusing on quality and data integrity. Assist the QA organization in auditing and monitoring clinical research organizations. Responsible for trial master files for clinical studies and R&D/Clinical database registration for the studies.
Stay current on trends in the cosmetic field, on clinical measurement science and technological developments and clinical methodology.
Respond to requests from management, as necessary
Manages day-to-day testing with external laboratories to ensure timely execution of clinical studies (sample registration and release, study protocol and report, data analytics and communication).
Create, manage, and archive documentation for clinical studies following GXP. Work with internal cross-functional partners to ensure data integrity and compliance.
Monitor/audit external laboratories to ensure fully compliance with internal and external requirement.
Performs other related duties as required by management which can include special projects or initiatives.
Must have experiences in clinical testing with 3 years in a clinical related role. Familiar with all the key clinical elements including recruiting, protocol, consent form, case report form, clinical measurement, study report and statistics.
Must have experiences working with external labs or CRO; experience in clinical testing in skincare preferred.
Experience with Good Clinical Practices and clinical study monitoring;
Ability to manage multiple projects in a fast-paced setting while maintaining attention to details and quality in the process..
Working knowledge of Microsoft Office applications: Word, Excel, and Outlook.
出差 接受，25 % 的时间
工作 Research & Development
主要地点 Asia Pacific-CN-上海
品牌 Estée Lauder Companies
Job Number: 200700