Benjamin Thai

Supported a Japanese health authority inspection, contributing to the approval of a global Phase III trial in Vietnam for a COVID-19 self-amplifying mRNA vaccine. Relocated to Hanoi, Vietnam, to oversee TMF inspection readiness activities for five months, ensuring the eTMF met regulatory standards. Supported PMDA, EMA, and BLA regulatory filing submission for pivotal phase III.

Assisted in restructuring $200 million in clinical operations cost savings for a Fortune 500 company spin-off. Developed and maintained financial and operational models to assess client performance. Conducted benchmarking analyses using internal and external data and performed biopharmaceutical-related research.

Collaborated with cross-functional teams to develop clinical research forms (CRFs) and EDC for a Phase III on opioid cessation. Led a team of data analysts in developing interim monitoring reports, safety monitoring parameters, and UAT testing. Identified and resolved data inconsistencies and ensured accuracy in case report forms per protocol guidelines.

Oversaw eTMF management for the clinical operations team, ensuring compliance with ICH and FDA guidelines. Acted as the primary liaison between internal functional leads and clinical research offices, managing vendor contracts, SOPs, RFPs, and clinical hematology project budgets. Recorded clinical study minutes, conducted EDC UAT testing, ensured GCP compliance, and facilitated patient advocacy ou

Achieved a 99.4% coding accuracy score in an audited, NIH-funded, multi-center Phase III clinical trial on calcineurin inhibitor-free interventions for graft-versus-host disease prevention. Executed key clinical trial processes, including patient randomization, SAE reporting, CRO coordination, and IRB submissions. Managed sample shipments in strict adherence to the study protocol.

Completed a Master of Public Health program. Focused on public health principles and practices.

Grade: Dean's List 13’16’

Activities and societies: Tufts Health Fellow, Dean’s List 13’16’, Health Career Connection Alumni, Janey Scholar 12’

Earned a Bachelor of Science degree with a focus on Biology and Community Health. Recognized for academic achievements including Dean's List.