Biomarker & Bioanalysis Scientific Coordinator
Core
Coordinate bioanalysis and biomarker assay activities, ensuring timely delivery of lab and data readiness to support clinical development and regulatory submissions.
Role type
Senior IC scientific coordinator (bioanalysis/biomarker)
Builds
Clinical study data and submission-ready documents for regulatory authorities
Domain
Pharmaceutical clinical development / bioanalysis
Required skills
Project management, time management, problem solving, operational knowledge of bioanalysis/biomarker activities, vendor management, logistics coordination, regulatory knowledge (ICH/GCP/GLP)
Preferred skills
Laboratory or data management background, immuno-assay knowledge, drug development process knowledge, China regulation knowledge
Technologies
Bioanalytical platforms, CRO systems, Laboratory Information Management Systems (LIMS)
Responsibilities
Coordinate with China CPPB and global stakeholder teams; Collect and maintain external CRO information and quotations; Track study-level activities, timelines, and milestones; Coordinate logistics for critical study materials; Collaborate with Clinical Pharmacology and Bioanalysis leads.
Seniority
Mid-level, hands-on IC