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 )