Michael Si-Hom Chau
Tmf Lead @ICON plc
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WORK HISTORY
Tmf Lead @ICON plc
Swansea, GB
Responsible for the complete and accurate TMF through documentation of quality, consistency and timely filing across all assigned clinical trials. Responsible for ensuring clinical trial documentation is consistent with TMF specifications, applicable SOPs, ICH-GCP guidelines, regulatory agency and local authority requirements. Ensures that TMF is submission and inspection ready. Support with qualification and surveillance audits in regards to TMF activities
EDUCATION
Swansea University / Prifysgol Abertawe
Bachelor's degree, Biochemistry
Swansea University / Prifysgol Abertawe
MSc by Research, Materials Engineering
ABOUT MICHAEL SI-HOM CHAU
Current TMF Lead at ICON plc working in collaboration with pharmaceutical and biotechnology companies for drug development. I am responsible for TMF setup and completeness. I ensure that TMF systems are inspection ready and actively participate in audits.
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