Job Description
Responsibilities: Providing operational status reporting of specific studies and projects to Clinical team members. Responsible for the delivery of data management components of clinical studies including the DMP and its constituents Review cost estimates for data management activity for allocated studies Support multiple clinical trials, across diverse therapeutic areas, to successful conclusion and provide technical oversight when required Provide both protocol and procedural training to external vendors and investigator's site Act the as primary contact for all data management problems, issues and questions from sites and be responsible for ensuring complete, accurate and consistent data for reporting to regulatory bodies Qualifications & Experience: - Bachelor's degree or equivalent experience - A significant amount of pharmaceutical or CRO experience, specifically in data management. - Understanding of region specific regulatory requirements and providing guidance on submission documents and datasets - Strong understanding of clinical trial methodology, Good Clinical Practice (GCP) and medical terminology - Fluent in both English and Chinese |