China (Senior-) Precision Medicine Operation Manager

• Provide operational expertise to implement clinical biomarker and diagnostic strategies within clinical trials in China, ensuring timeline and audit readiness.
• Ensure appropriate sample and assay quality, define corrective actions for study issues, and escalate issues as necessary.
• Accountable for sample management strategy deployment and manage key activities with laboratory partners, including technical qualification, sample analysis plans, validations, and analytical reports.
• Ensure all activities are completed within time, quality, and budget requirements, aligned with agreed sample and assay management strategy.
• Provide regular study-level status updates for areas of accountability/responsibility to key stakeholders.
• Provide expert input into Clinical Trial documentation, including Protocols, Informed Consent Forms, data transfer agreements, lab manuals, and lab specifications.
• Proactively identify challenges across the sample, assay, and data operations space impacting the delivery of China Precision Medicine strategy.
• Create and deliver solutions for simplifying sample, assay and data operations practices to increase productivity, maximize value, and remove redundant activities.
• Ensure compliance with all company policies and procedures relating to HGRAC regulation, Human Subject Research, Individual Human Data, and good data practices.
• Contribute to functional process and system improvements to ensure operational excellence.
• Support other activities as required.

Qualifications

• Bachelor's degree in a science or health-related discipline.
• Experience in clinical trial specimen management, including collection/processing of diverse sample types, laboratory management, LIMS, and project management.
• Demonstrated knowledge of the clinical development process, GxP, and global and China-specific regulatory requirements for sample analysis, including sample exportation.
• Excellent communication skills, interpersonal skills, and matrix working skills.
• Self-motivated with the ability to work independently, as well as a highly motivated team player with a proactive attitude and ability to interact effectively within a multi-disciplinary team, including internal and external technical and business experts.
• Demonstrated attention to detail.

• Master's degree, or equivalent experience.
• Experience with managing the generation and flow of high-dimensional biomarker datatypes (e.g., IHC, imaging, NGS, proteomics).
• Experience with validation and implementation of biomarkers.
• Experience with clinical biomarker and diagnostic development.
• Good understanding of scientific R&D processes.
• Familiarity/knowledge of data governance and privacy considerations regarding the use and re-use of human subject data.
• Experience in clinical data management, quality, and governance, or external collaborative engagements.

Additional Information

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