Jerry Lin
Summary
Clinical research professional with over 14 years of experience, including 7 years in project management.
Overview
15
15
years of professional experience
Work History
Project Manager
A2 Healthcare Taiwan
11.2016 - Current
- Managed clinical studies to meet timelines and sponsor expectations
- Coordinated cross-functional teams for milestone achievement and compliance
- Acted as primary contact for sponsors, liaising with investigator sites and CROs
- Monitored team performance, leading problem-solving and risk management
- Identified quality issues and implemented corrective actions
- Provided input for proposals and managed project budgets
- Prepared and reviewed study documents
- Participated in proposal development and bid-defense processes
- Co-monitored/accompanied CRA on-site visits, mentored CRA team
- Led study teams for GCP inspection.
Clinical Research Associate III
PRA Health Science, Inc
05.2015 - 11.2016
- Implemented and monitored clinical trials for regulatory compliance
- Assessed sites, initiated and closed trials, instructed site personnel
- Managed IP accountability, dispensation, compliance, and safety reporting
- Conducted source document verification, query resolution, and monitoring documentation
- Underwent internal and external audits without critical findings.
Senior Clinical Research Associate
ICON – DOCS
02.2015 - 04.2015
- Conducted and coordinated clinical study activities
- Negotiated and reconciled site budgets
- Managed site activities, interim monitoring, and staff training.
Associate Clinical Research Manager
TTY Biopharm Company Limited
10.2014 - 01.2015
- Managed Medical Affairs Department operations
- Led projects for authority filings, registrations, and clinical trials
- Supervised study processes and resource allocation
- Reviewed monitoring reports and coached team members.
Senior Clinical Research Associate
TTY Biopharm Company Limited
11.2011 - 09.2014
- Conducted and managed clinical studies
- Managed budgets, RA and IRB submissions, site management, SAE reporting, site initiation/close-out, interim monitoring, and audits
- Coached junior CRAs.
Clinical Research Associate
TTY Biopharm Company Limited
08.2009 - 10.2011
- Conduct and coordinate clinical study activities
- Managed RA and IRB submissions, site budget negotiation, payment reconciliation, site management, safety reporting, site initiation/close-out, interim monitoring, and audits.
Education
Master of Science - Pharmacology
National Taiwan University
Taiwan 04.2001 -
Bachelor of Science - Microbiology
National Chiayi University
Taiwan 04.2001 -
Therapeutic Areas
Oncology
- Acute Myeloid Leukemia
- Advanced refractory solid tumor
- Colon Cancer
- Colon Cancer (Cell therapy)
- Biliary Tract Cancer
- Breast Cancer
- Glioblastoma Multiforme
- Head and Neck Cancer
- Hepatocellular Carcinoma
- Non-Hodgkin Lymphoma
- Non-Hodgkin Lymphoma (CAR-T)
- Non-small Cell Lung Cancer
- Pancreatic Cancer
Dermatology
- Donor Site Wound (Cell therapy)
- Female hair loss
Infectious Disease
- Hepatitis C
- Pneumonia associated with SARS-CoV-2 and Influenza
Musculoskeletal System Disorders and Joint Diseases
- Knee Osteoarthritis (Cell therapy)
Languages
Mandarin Chinese (Native Language)
English
Timeline
Project Manager
A2 Healthcare Taiwan
11.2016 - Current
Clinical Research Associate III
PRA Health Science, Inc
05.2015 - 11.2016
Senior Clinical Research Associate
ICON – DOCS
02.2015 - 04.2015
Associate Clinical Research Manager
TTY Biopharm Company Limited
10.2014 - 01.2015
Senior Clinical Research Associate
TTY Biopharm Company Limited
11.2011 - 09.2014
Clinical Research Associate
TTY Biopharm Company Limited
08.2009 - 10.2011
Master of Science - Pharmacology
National Taiwan University
04.2001 -
Bachelor of Science - Microbiology
National Chiayi University
04.2001 -