As China (Senior-) Precision Medicine Operation Manager, you will provide operational expertise to consistently implement the operational delivery of Precision Medicine strategies of clinical trials conducted in China, ensuring timely delivery of testing lab readiness, quality data and audit readiness at all times. You will be responsible for ensuring the appropriate level of sample and assay quality, defining corrective actions if necessary, and escalating issues when appropriate.

Key Responsibilities

• 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.