Specialist II / Senior Specialist, Clinical Data Strategy and Operations Group, Japan Data and Statistical Sciences
Core
Senior data management specialist supporting clinical development projects in Japan and China, ensuring data integrity from study start-up through regulatory submission.
Role type
Senior Specialist, Clinical Data Management
Builds
End-to-end data management activities for clinical trials in Asia
Domain
Pharmaceutical R&D, Clinical Data Management
Required skills
Data management, CDISC (SDTM), ICH E6(R3), Operational analytics, Project management, Risk-based data review, Regulatory compliance (GCP, ICH), Cross-functional communication, Process improvement, Mentoring
Preferred skills
Chinese language proficiency, Master's or Doctor's degree in quantitative/scientific field
Technologies
EDC, eCRF, eCOA, IRT, SDTM
Responsibilities
Own data-related start-up deliverables from protocol development through system go-live, Lead data management activities end-to-end, Perform risk-based continuous data review, Define and manage study data flow from raw EDC to mapped SDTM, Support regulatory submissions and maintain inspection readiness, Coach and mentor team members
Seniority
Senior, hands-on IC with mentorship responsibilities