Translational Medicine Business Operation Specialist
Primary Location: China, Shanghai Shinmay 求人ID R0000044193 Category Clinical Trials
About this Role
With guidance from the Translational Medicine leader, and working closely with the clinical team, procurement, and other supporting functions, the role supports translational medicine operations, external vendor and contract management, clinical trial and documentation support, compliance, and team administrative and operational support, in the following areas:
Translational Medicine Project Management
- Support Translational Medicined Leads and Project Managers by completing delegated study work.
- Support the delivery and execution of the biomarker plan for clinical studies by sample logistic management, including but not limited to support biomarker samples shipment to testing labs, testing data delivery tracking and oversight.
- Be accountable for the time, cost, and quality of agreed deliverables.
- Manage and maintain department and project documentation, ensuring documents are accurate, current, version-controlled, and appropriately filed in line with company standards and quality requirements.
External Vendor and Contract Management
- Manage external alliances and support China TM activities including vendor qualification and renewal (eg. risk assessment and quality assessment), vendor evaluation, and collaborations.
- Work effectively with procurement to contract biomarker operations, delivering fit-for-purpose laboratory testing from sample receipt to delivery of results, compliant with clinical sample testing guidelines where necessary.
- Ensure biomarker plans commit CROs/laboratories to deliver clinical testing to agreed time, cost, and quality.
Administrative and Operational Support
- Provide general administrative support to the TM team, including organizing and preparing for meetings, maintaining records and documents, and attending to day-to-day operational tasks.
- Coordinate logistics for team meetings, events, seminars, and leadership visits, ensuring local arrangements are effectively coordinated and executed.
- Support onboarding activities for new staff and coordinate scheduling, travel arrangements, and routine team administration.
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