Yan Su苏燕
Clinical Operations Leader — FSP, Outsourcing & Clinical Quality
21 years in clinical operations. 16 of them inside sponsor systems — running delivery, quality and P&L for global pharmaceutical companies in China.
About
I have spent 21 years in clinical operations — 7 as a CRA, 2 in full-service CRO project management, and 12 leading teams of up to 170. Sixteen of those years were under FSP models, working inside sponsor systems: their SOPs, systems, audits and governance. At IQVIA, the client had a single oversight lead, and every process from feasibility to close-out ran through me.
I have led FSP businesses with full P&L accountability, grown billable headcount 55% in twelve months, and maintained zero critical findings in sponsor audits and regulatory inspections. My therapeutic depth is in infectious disease and cardiovascular, with broader experience across endocrinology, nephrology, ophthalmology and oncology.
I also run 老猫干货铺 (Laomao Ganhuopu), a clinical research publication for frontline CRAs, CTAs and project managers.
I am now looking for a China clinical operations leadership role on the sponsor side — where execution depth, quality discipline and accountability actually matter.
Experience
Beijing
- Led the China FSP business across ~10 external sponsor clients; end-to-end clinical quality across all outsourced projects.
- Full P&L accountability; grew billable headcount 55% to a peak of 140; restructured the organization and improved cost efficiency.
- Built quality and training frameworks with zero critical findings in sponsor audits and regulatory inspections.
Beijing
- Led four global MNC sponsor FSP teams across Greater China; peak team size 170.
- Owned full-lifecycle quality supervision, resource allocation and sponsor relationship management.
- Launched manager development forums to align quality execution with sponsor standards.
Beijing
- People manager and FSP client lead for global pharmaceutical sponsors; max team 83.
- Deep familiarity with sponsor internal clinical operations and audit processes.
Beijing
- FSP CRA stationed at a leading global MNC for four years; then CRO project management and people management.
- Phase III and Phase IV trials across oncology, transplantation, cardiovascular and infectious disease.
Writing
Technical, practical content for frontline CRAs, CTAs and project managers — monitoring, site management, quality and delivery. Search the account name in WeChat.
