Onsite Clinical Study Specialist I — Precision & Compliance

caprion; Antwerpen; Sur place; EUR 60 000 - 80 000; Plein temps

Résumé du poste

CellCarta is seeking an energetic Clinical Study Specialist I to support oncology trials, ensuring site-level regulatory docs, monitoring visits, and action item follow-up are precise and compliant.

You will liaise between Project Management, Regulatory Affairs, and QA, driving site initiation activities and eTMF integrity across a diverse trial portfolio. 100% onsite in Belgium is required.

Qualifications

• 2+ years of hands-on clinical research experience.
• GCLP and GDP knowledge required.
• Familiarity with oncology trial documentation.
• Experience with eTMF systems (e.g., Veeva Vault) and CTMS.
• Professional English fluency mandatory.

Responsabilités

• Monitoring Oversight & Action Item management: review monitoring reports and drive action items to resolution.
• Site Startup & Activation: collect and file site-level essential documents for SIVs and activation.
• Close-Out Visit & Study Deactivation: oversee close-out logistics and reconcile documents before site closure.
• RA & QA Collaboration: prepare package for Regulatory Affairs submissions and maintain audit-ready eTMFs.
• System & Logistics Facilitation: manage access to trial systems (EDC, IRT, eTMF) and organize docs for meetings.
• Cross-Trial Process Optimization: maintain dashboards to provide real-time visibility into open actions and compliance.

Connaissances

Clinical research

GCLP GDP

eTMF CTMS

English fluency

Organizational skills

Formation

Life Sciences/Pharmacy degree

Outils

Veeva Vault

CTMS

Description du poste

CellCarta is seeking an energetic Clinical Study Specialist I to support oncology trials, ensuring site-level regulatory docs, monitoring visits, and action item follow-up are precise and compliant.

You will liaise between Project Management, Regulatory Affairs, and QA, driving site initiation activities and eTMF integrity across a diverse trial portfolio. 100% onsite in Belgium is required.