China Biomarker Studies Asset Manager

As a China Biosample Operations Asset Lead, you will provide biosample operational expertise to cross-functional local and global study teams, ensuring compliance with quality standards and local regulations throughout the study lifecycle.

Responsibilities include:

• Planning, coordinating, and overseeing the lifecycle of study samples, including collection, processing, analysis, and data delivery.
• Leading the development of China-specific biomarker management plans and providing input for HGRAC applications.
• Partnering with biomarker scientists and global teams to align sample collection strategies and evaluate operational feasibility.
• Managing China biosample vendors, including scope of work, budget, and performance oversight.
• Tracking biosample metrics and coordinating with data management to ensure accurate data delivery.
• Contributing to process improvements and internal guidelines based on HGRAC regulations and program needs.

Requirements:

• 3+ years of professional experience in clinical research, clinical/diagnostic laboratories, or pharmaceutical/biotechnology R&D.
• Life Sciences degree in a scientific, medical, or healthcare field; PhD or project management certification is a plus.
• Extensive experience in clinical development and biological sample processing or analysis.
• Proven leadership skills with the ability to work effectively in global, multi-cultural, and matrix environments.
• Strong knowledge of drug development processes, ICH/GCP guidelines, and HGRAC regulations.
• Fluent in English with excellent communication and negotiation skills.