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- 职位介绍
- 职责描述： - Provides data management CRO oversight and takes data management accountability for one or more low to moderate complexity trials. Facilitates real-time inspection readiness of all China DM deliverables for clinical trial and works on archiving documents for trials； - Makes recommendations and influences decisions to trial processes in line with business needs and in support of Clinical Development and Medical Affaires clinical studies. Looks over DM CRO project timelines and ensure quality of DM deliverables by CRF DM. Oversees E2E processes for China MAF trials； - Participates in process, system and tool improvement initiatives within China DM and presents at investigator and monitor meetings if assigned； - Works with Data Management Leader to facilitate compliance with regulatory guidelines. Consults with internal clients on DM issues in trial set-up, trial conduct and database lock activities. 任职要求： - Bachelor/Master or above degree in a scientific discipline or health related field； - Full understanding of relevant regulatory guidelines, GCP and international guidelines regarding data management； - Understanding of the clinical drug development process in the pharmaceutical industry； - Experience with DM systems e.g. Medidata Rave, ClinTrial, InForm； - Understanding of current industry standards (CDISC, SDTM, CDASH...) and of technology platforms for data exchange； - Requires ＞= 6 years of experience in data management and in clinical drug development in the pharmaceutical industry； - Diligent and serious, precise thinking, strong sense of responsibility and accountability. Results and performance driven, sense of urgency. Team spirit, attention to details and good self-awareness； - Good written and great verbal communication skills in Chinese and English. Being able to give presentations and actively participate in meetings in both Chinese and English.
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