Wuliang Si
Clinical Research Operation Expert, Project Management Consultant, Quality Assurance, Quality Control, Certified DPO based on GDPR & PIPL @ SUZHOU MDCE CO., LTD
About
I specialize in providing comprehensive clinical trial project management services with a global reach, based in China. With extensive experience in the field, I offer expertise in various areas, including but not limited to: *Regulatory Affairs *HGRAC Specialist *Start-up and Contract Specialist *Site Relationship and Site Care Partner *Medical Devices *Rare Diseases *Observational Studies *IIT *Translator *GCP QA/QC *Study Subjects Recruiter My skill set encompasses a wide range of clinical trial services, from IND to NDA . *PI Selection and Study Feasibility *Ethics Committee (EC) and Regulatory Authority (RA) Submissions *HGRAC Application *Site Start UP(SSU) *Budgeting Negotiation *Site initiation and Training *Source Data Verification (SDV), Site Monitoring, Co-Monitoring, and Oversight Monitoring *FDA and NMPA Inspections *Sponsor and Internal Good Clinical Practice (GCP) Auditing *Subject Recruitment *Serious Adverse Event (SAE), Suspected Unexpected Serious Adverse Reaction (SUSAR), and Pharmacovigilance By leveraging my expertise, I ensure the successful management and execution of clinical trials, delivering high-quality results and adhering to regulatory standards. Let's connect and discuss how I can contribute to your clinical trial projects.
China
Pudong
Pharmaceuticals
Clinical Research Associates, Clinical Research, Clinical Trials, GCP, ICH-GCP, CRO, Clinical Monitoring, CTMS, Clinical Development, Pharmaceutical Industry, Microsoft Project, Visio, Project Management
Experience

Global Project Management
中国
For China and global clinical research consultant, can provide services include but not limited :clinical research monitoring, study design, regulatory advisory, quality control& quality assurance, HGRAC management, project management, training. Responsible for and managing clinical research projects including Phase I to IV, BE, IIT, Medical Devices etc,. covering regions such as the United States, Singapore, Australia, EU,Africa (Mali, Mozambique), HK and Taiwan

CRA
R&G PharmaStudies Co.,Ltd
Shanghai City, China

Clinical Research Association
Beijing Panaceacro ltd
CRA
Wuliang Si's Contact Information
Phone
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