Clinical Trial Assistant

Location in West side of  Singapore paying up to $6500 1 year contract  About the Role Join a Clinical Research Unit (CRU) in Singapore to play a central role in driving high-quality clinical trial operations across global markets. We are seeking a detail-oriented  Clinical Trial Assistant (CTA)  with direct  sponsor-side experience  and a strong foundation in  Trial Master File (TMF/eTMF)  management. In this role, you will work closely with Clinical Project Managers (CPMs) to manage trial documentation, budget tracking, vendor workflows, and logistical activities across multi-center studies. Key Responsibilities eTMF Governance & Inspection Readiness:  Lead the end-to-end setup, routine filing, quality control (QC) review, and archiving of electronic Trial Master Files (eTMF) in full alignment with ICH-GCP guidelines and internal SOPs.

Sponsor-Side Vendor Oversight:  Monitor Contract Research Organizations (CROs) and third-party vendors, developing TMF specifications, review guidelines, and executing routine document filing audits.

Financial & Budget Administration:  Assist CPMs with vendor onboarding, purchase order (PO) generation, good receipts tracking, invoice reconciliations, and routine budget tracking in SAP/financial tools.

Clinical Logistics & Site Support:  Coordinate clinical supply logistics, trial ancillary shipments, and site enablement tools while assisting with trial registration on  ClinicalTrials.gov .

Ethics & Regulatory Submissions:  Conduct quality reviews on protocols, Informed Consent Forms (ICFs), and promotional materials to ensure strict compliance with health authority regulations and ethics boards (IRBs).

Cross-Functional Communication:  Facilitate global study communications, organize investigator meetings and Site Initiation Visits (SIVs), and manage agendas, action logs, and minutes.

skills and Requirements Education:  Bachelor’s degree in Healthcare, Life Sciences, Biomedical Science, or a related field.

Clinical Trial Experience:  Minimum  2–3 years of clinical trial administration experience , with explicit preference for  sponsor-side  or CRO-sponsorship management exposure.

TMF Expertise:  Hands-on proficiency with electronic Trial Master File systems (eTMF) and clinical trial management systems (CTMS/Veeva Vault). Proven track record of handling eTMF QC reviews and audit readiness.

Regulatory Knowledge:  Deep understanding of ICH-GCP guidelines, local health authority regulations (e.g., HSA), and SOP governance.

Systems & Tools:  Proficient in Microsoft Office (Advanced Excel), SAP procurement/financial tracking modules, and electronic document management systems (EDMS).

Please click on the 'apply' button to apply online. For more information, please reach out to Wai Ling Tai. (EA: 94C3609 /  R1110392  )