Clinical Trial Assistant
VermittlerGefragte Skills
Stellenbeschreibung
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 )
Quelle: mycareersfuture.gov.sg. Für die Inhalte der Inserate übernehmen wir keine Haftung.
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