Anzeige
Zurück
R

Clinical Trial Assistant

Vermittler
RANDSTAD PTE. LIMITED
Singapore · 10294 km · vor 1 Tagen
FreelanceVor OrtS$6'000–7'000/Mt.
Matching nur mit Login und CV verfügbar
Lade deinen CV hoch und sieh sofort, wie gut jeder Job zu dir passt.
Anmelden

Gefragte Skills

HSDPADocument Management SystemQuality ControlICH-GCPHealthcareaudit paperworkmedical fieldAdvanced Microsoft Excel
Anzeige

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.

Bewerbungstext erstellen

Wir erstellen aus deinem Profil und dieser Stelle einen Entwurf. Du prüfst und passt ihn an.

Nur mit Konto verfügbar.

Jetzt anmelden
Anzeige

Ähnliche Stellen