PM, Clinical Operation

Sanegene Bio is a global, venture-backed, clinical-stage biotech company advancing best-in-class genetic medicines. Powered by our proprietary LEAD™ siRNA delivery and chemistry platform, we are developing innovative RNAi therapeutics for cardiometabolic and autoimmune diseases. With R&D operations across the U.S. and China, we foster a culture of scientific rigor, collaboration, operational excellence, and continuous innovation.

We are seeking an experienced Clinical Operations professional to support the execution of global clinical trials. The role is responsible for driving study delivery through cross-functional coordination, vendor management, and operational oversight from start-up to close-out, ensuring high-quality, timely, and compliant execution.

• Manage clinical trial projects in China and overseas, including monitoring study progress, quality, and budget execution.
• Participate in the development of overall clinical development plans and clinical trial protocols.
• Lead the selection and evaluation of clinical trial sites, CROs, SMOs, and other service providers.
• Draft, review, and finalize key clinical trial documents, including study protocols, source documents, CRFs, clinical trial operation manuals, laboratory manuals, and clinical study reports.
• Develop project management plans in accordance with study protocols, including team allocation and budget planning, and update these plans as the project progresses.
• Establish and maintain effective collaboration with investigators, clinical sites, CROs, SMOs, and other vendors to ensure smooth study execution.
• Communicate and coordinate effectively with cross-functional stakeholders as needed, including medical writing, data management, and biostatistics teams.
• Provide regular updates on study progress and prepare project status reports.
• Support quality oversight and management of clinical trial execution, including co-monitoring activities at key sites when necessary, ensuring compliance with protocols, SOPs, and applicable regulations.
• Coordinate internal audits and quality assurance activities related to clinical trial projects.
• Participate in regulatory submissions and other R&D-related project activities as required.

• Background in biochemistry, medicine, or related life science disciplines, with more than 6 years of clinical trial operations and project management experience.
• Strong professional writing skills, including formal and regulatory documentation.
• Proficient in English communication, reading, and writing.
• Excellent time management, communication, coordination, and problem-solving skills./li>