Jenny Li Email & Phone Number

Jenny Li Skills

• Timeline management
• Clinical Trial Management in Biopharmaceutical and Device Companies
• Strategic Planning and Execution
• Vendor Management
• Clinical Monitoring
• Clinical Data Management
• Business Process Improvement
• Design Control
• Risk Management
• CTMS
• Leadership
• Critical thinking
• Negotiation
• Business Relationship Management
• Coaching
• Creative Problem Solving
• Clinical Study Design
• Drug Safety
• TMF management
• Enrollment Management
• FDA Inspection Readiness
• Communication and collabration
• Project recovery
• Trial Quality Management
• Buidling EDC Database
• Self-confidence
• Knowledge in Clinical Trial Regulations (e.g. GCP, ICH, MDR, etc.)
• Self-management
• Life-long Learner
• Regulatory Submissions (e.g. IND, NDA, CE Mark, 510K, Orphan Drug etc.)
• Medical writing (e.g. SOPs, Study Startup Materials, CSRs, Study Abstracts, Study Publications, Annual Reports, Package Inserts, etc.)
• Global Trial Management (e.g. EU, Canada, China, Japan, Kenya, etc.)
• Dependability and Hard Worker
• Open to Feedbacks
• Therapeutics: Oncology, immunology, hematology, CNS, cardiology, infectious disease, women's health, endocrinology, nephrology, dermatology, pulmonology, GI, urology, and vaccines
• Pragmatics
• IRB and EC Submissions
• Site Management
• Pharmacy, Pharmacology, Pharmacokinectics, Pharmacodynamics, Pharmaceutics
• Cross-Functional Team Management
• Flexible to changes
• Customer service passion
• Attention to details
• Manage up
• Listening skills
• Conflict Resolution
• Microsoft Word, Excel, PowerPoint or Electronic Data Capture (EDC) systems
• Drug Development
• Internal TMF audits
• CRO Management