YAN SU 苏燕
Beijing, China · yan.su@yansuclinical.com · yansuclinical.com
Clinical Operations Leader · Full CV available on request
SUMMARY
Clinical operations leader with 21 years in the industry — 7 as a CRA, 2 in full-service CRO project management, and 12 in people and operational leadership. Sixteen of those years were spent under FSP models, working inside sponsor systems: sponsor 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. Have led teams of up to 170 and grown a China FSP business 55% in twelve months. Therapeutic depth in infectious disease and cardiovascular, with broader experience across endocrinology, nephrology, ophthalmology and oncology (portfolio oversight).
CORE STRENGTHS
- Clinical operations leadership across FSP and full-service models
- Sponsor governance, audit and inspection readiness
- P&L, budget and resource management
- Quality systems, GCP compliance and HGRAC
- Building and developing large teams (up to 170)
- Cross-functional and cross-cultural stakeholder management
EXPERIENCE
Parexel China — Senior Director, Clinical Operations / China FSP Head
Sep 2025 – Aug 2026 | Beijing
- Led the China FSP business across ~10 external sponsor clients, accountable for end-to-end clinical quality across all outsourced projects.
- Held full P&L accountability — budget, headcount profitability and cost control.
- Grew billable headcount 55% in twelve months, reaching a peak of 140.
- Managed up to 140 FTEs across FSP and hybrid delivery models.
- Restructured the organization and optimized manpower cost, improving cost efficiency while maintaining delivery quality.
- Built a standardized training and quality framework aligned with sponsor compliance requirements; maintained zero critical findings and no significant quality findings in sponsor audits and regulatory inspections.
- Partnered with clients on talent recruitment and cross-department coordination; supported new business development.
ICON China (legacy PRA Health Sciences) — Director, Clinical Operations / FSP Regional Lead, Greater China
Apr 2019 – Aug 2025 | Beijing
- Led four global MNC sponsor FSP teams across Greater China for six years; peak team size 170.
- Owned full-lifecycle quality supervision, cross-team resource allocation and sponsor relationship management.
- Identified new project opportunities and supported account growth.
- Launched regular manager development forums to align quality execution with sponsor standards.
- Direct reports included CRA Managers, Project Managers, a Quality Specialist, an HGRAC Manager and frontline CRAs.
IQVIA China (legacy Quintiles / Quintiles IMS) — Director, Clinical Operations
Feb 2014 – Apr 2019 | Beijing
- Progressed from Associate Clinical Operations Manager to Director over five years.
- Served as people manager and then FSP client lead for global pharmaceutical sponsors.
- Managed full project quality, CRA recruitment, site oversight and cross-team coordination.
- Max team size 83, supervising operation managers, CRAs, CTAs and trainers.
Fortrea Clinical Development Services (legacy Covance / LabCorp) — Associate Clinical Operations Manager / Clinical Team Lead
Jun 2008 – Feb 2014 | Beijing
- Spent the first four years as an FSP CRA stationed at the office of a leading global MNC pharmaceutical company.
- Moved into CRO project management and people management for CRAs.
Earlier Career
- Rundo International Clinical Research, Beijing — CRA (2006–2008)
- Beijing Vision Drugs Development, Beijing — CRA (2005–2006)
- Boai International Medical Investment & Management, Beijing — Project Manager (2004–2005)
- My Young Cosmetic Hospital, Beijing — Assistant to President (2004)
- Affiliated Hospital of Ningxia Medical College, Yinchuan — Medical Affairs Specialist (1999–2003)
THERAPEUTIC & STUDY EXPERIENCE
- Infectious diseases — candidiasis, C. difficile, aspergillosis, hepatitis C, surgical site infection; Phase III, 2008–2012
- Cardiovascular — heart failure, atrial fibrillation, hyperlipidemia; Phase I–III, 2008–2025
- Endocrinology & nephrology — type 2 diabetes, chronic kidney failure; Phase III, 2008–2024
- Ophthalmology, women's health & transplantation — glaucoma, AMD, endometriosis, menopausal symptoms, transplant rejection / CMV; Phase III–IV, 2006–2025
- Oncology (portfolio oversight) — lung, colorectal, hepatocellular, multiple myeloma, ALL; Phase III, global and local, 2005–2019
PROFESSIONAL INFLUENCE
- Sole operator of 老猫干货铺 (Laomao Ganhuopu), a WeChat official account on clinical research practice for CRA, CTA and PM audiences.
EDUCATION & CERTIFICATIONS
- Bachelor of Medicine, Beijing University of Chinese Medicine, 1994–1999
- PMP, 2017
- Self-study, Chinese Law, 2000–2003
LANGUAGES
Chinese (native) · English (fluent)