Veeva Vault
Daniel Ho
TMF Reviewer
Summary
Experienced in supporting over 10 global, multi-site Phase I–IV clinical trials across oncology, neurology, rheumatology, ophthalmology, and dermatology, in collaboration with both pharmaceutical and biotech sponsors. Currently serving as a TMF Reviewer at Parexel with over one year of hands-on experience in Trial Master File (TMF) management , including completeness checks, milestone reviews, audit preparation, and eTMF system usage.
Demonstrated ability to collaborate effectively with CRAs, Regulatory Affairs, and Project Specialists to ensure documentation accuracy, streamline workflows, and maintain inspection readiness. Brings strong organizational and time management skills, with a solid foundation in ICH-GCP and TMF best practices.
Overview
3
3
years of professional experience
5
5
Certifications
3
3
Languages
Work History
TMF Reviewer
Parexel
08.2024 - Current
- Supported over 10 global multi-site Phase I–III and observational Phase IV clinical trials, ensuring TMF integrity and compliance across oncology, neurology, rheumatology, ophthalmology, and dermatology.
- Performed TMF completeness checks, milestone reviews, and contractual documentation tasks in alignment with SOPs, achieving 100% on-time milestone QC review completion.
- Gained familiarity with Local and Central Ethics Committee (LEC and CEC) submission processes across Taiwan, US, Canada, Germany, Australia, France, Poland, Romania, Chile, and Argentina through TMF preparation support.
- Collaborated with TMF readiness specialists to plan and execute TMF activities, maintaining adherence to timelines, SOPs, and sponsor quality standards.
- Facilitated internal and external audits by preparing TMF tour guides, responding to audit findings, and supporting inspection readiness activities.
- Supported TMF closure activities and prepared eCRF change logs following SOPs and sponsor requirements, ensuring compliant documentation management.
- Delivered proactive status updates and escalated key issues to study teams and TMF Inspection Readiness specialists to facilitate trial progress.
- Provided actionable feedback to PS-FL super-users to optimize Clinical Research System (CRS) technology and improve tools and processes.
Substitute Military Service
Ministry of Welfare and Health
06.2023 - 01.2024
- Nursing records management and hospital medical record reporting.
- Communicating resident's medical situation between physician and nursing home.
- Monitoring vital signs daily and accompanying residents to hospitals.
English Translator
探旅者旅行社
03.2023 - 06.2023
- Provided email-based customer support for Universal Studios Japan and the online ticketing platform, addressing service inquiries and issue resolution.
- Translating literature/product information to English.
- Address APAC region customer service and communicate with retailers.
Research Assistant
Dr. Tsai Jin Wu's Lab - NYCU
06.2022 - 10.2022
- Established MKS1 Knock-out cell model.
- Executed routine lab administration and equipment maintenance.
Education
Master of Science - Brain Science
National Yang-Ming Chiao-Tung University
09.2020 - 2022.06
Bachelor of Science - Life Science
Fu Jen Catholic University
09.2016 - 2020.06
Skills
Veeva Vault
Certification
NIDA Clinical Trials Network GCP certification
Awards
- Samuel Yin Scholarship (College of Medicine, NYCU)
- IBS Open house Coordinator, NYCU
Software
Timeline
TMF Reviewer
Parexel
08.2024 - Current
Fundamentals of Good Clinical Practice: Prep and Personnel - Novartis
05-2024
Fundamentals of Good Clinical Practice: Recruitment & Trial - Novartis
05-2024
Clinical Trials Management and Advanced Operations - Johns Hopkins University
05-2024
Substitute Military Service
Ministry of Welfare and Health
06.2023 - 01.2024
NIDA Clinical Trials Network GCP certification
03-2023
English Translator
探旅者旅行社
03.2023 - 06.2023
TOEIC 925/990
11-2022
Research Assistant
Dr. Tsai Jin Wu's Lab - NYCU
06.2022 - 10.2022
Master of Science - Brain Science
National Yang-Ming Chiao-Tung University
09.2020 - 2022.06
Bachelor of Science - Life Science
Fu Jen Catholic University
09.2016 - 2020.06
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