Senior TMF & Clinical Documentation Specialist

ARTO; Lyon; Sur place; EUR 42 000 - 52 000; Plein temps

Résumé du poste

ARTO seeks a Senior Clinical Trial Assistant to support Clinical Project Managers and CTMs in a fast-paced environment. You will manage TMF/eTMF documentation, ensure inspection readiness, and provide administrative support across trial activities.

Ideal candidates have 5+ years in clinical research, strong ICH-GCP knowledge, and familiarity with TMF/CTMS systems. Occasional travel to Lyon is expected, with an initial engagement through December 2026.

Qualifications

• Senior Clinical Trial Assistant with at least 5 years in clinical research.
• Travel to Lyon occasionally.
• Available to start mid-September 2026 and commit through December 2026.
• Experience in international clinical trials is a plus.

Responsabilités

• Assist in filing, tracking, and archiving of clinical documentation.
• Perform QC checks on TMF documentation for accuracy and compliance.
• Update TMF/eTMF documents in a timely manner.
• Create and maintain essential study documentation and communications.

Connaissances

ICH-GCP

eTMF

CTMS

Communication

Autonomy

Attention to detail

Proactive mindset

Teamwork

Formation

Bachelor's degree in life science

Outils

eTMF systems

CTMS systems

Description du poste

ARTO seeks a Senior Clinical Trial Assistant to support Clinical Project Managers and CTMs in a fast-paced environment. You will manage TMF/eTMF documentation, ensure inspection readiness, and provide administrative support across trial activities.

Ideal candidates have 5+ years in clinical research, strong ICH-GCP knowledge, and familiarity with TMF/CTMS systems. Occasional travel to Lyon is expected, with an initial engagement through December 2026.