Clinical Trial Assistant

ARTO; Lyon; Sur place; EUR 52 000 - 66 000; Plein temps

Résumé du poste

ARTO in France is seeking a Senior Clinical Trial Assistant to support the clinical team with filing, tracking, and archiving TMF/eTMF documentation, and to ensure inspection-ready records.

Based in Lyon with regular travel, you will perform QC checks, manage document updates, and collaborate with CTMs, CROs, and vendors to maintain regulatory-compliant study documentation.

Qualifications

• Senior Clinical Trial Assistant with at least 5 years in clinical research.
• Based in Lyon or willing to travel to Lyon in France.
• Available to start mid-September 2026 through December 2026.
• Experience in international clinical trials is a plus.
• Experience in TMF management and documentation management.
• Bachelor’s degree in life science.

Responsabilités

• Assist the clinical team with filing, tracking, and archiving of clinical documentation.
• Perform QC checks on TMF documentation for accuracy and compliance with regulatory and internal standards.
• Manage timely updates of TMF/eTMF documents.
• Support creation and maintenance of essential study documentation and regulatory compliant communications.
• Ensure TMF/eTMF is inspection-ready with the project team and collaboration with CTMs.
• Provide administrative support in clinical trial activities with CTMs and project teams.
• Coordinate with internal teams, CROs, vendors, and external partners to file study documentation in a timely manner.

Connaissances

ICH-GCP knowledge

eTMF/CTMS knowledge

Documentation management

Attention to detail

Autonomy

Communication skills

Process improvement

Teamwork

Clinical trial experience

Formation

Bachelor’s degree in life science

Description du poste

• Assist the clinical team in the filing, tracking, and archiving of clinical documentation.
• Perform regular quality control (QC) checks on TMF documentation to ensure accuracy, consistency, and compliance with applicable regulatory and internal standards.
• Manage the timely update of TMF/eTMF documents
• Participate in the creation and maintenance of essential study documentation, supporting the overall documentation strategy and ensuring regulatory compliance.
• Ensure the completeness and ongoing maintenance of the Trial Master File (TMF/eTMF) in close collaboration with the project team, maintaining it in a constant “Inspection Ready” state.
• Provide comprehensive administrative support in clinical trial activities in collaboration with the Clinical Trial Managers (CTM)
• Collaborate effectively with project partners and subcontractors to ensure seamless study execution.
• Support the preparation of essential study documentation and study-related communications.
• Participate in regular meetings with suppliers
• Participate in team meetings and ensure timely follow-up of assigned actions.
• Provide support to ensure the smooth and regulation-aligned progression of clinical trials.
• Assist the project team in the preparation, handling, distribution of the clinical documentation and reports.
• May participate in study audit/inspections, both internal and external
• Support the reconciliation, completeness review, and follow-up of missing or overdue TMF/eTMF documents.
• Coordinate with internal teams, CROs, vendors, and external partners to collect, review, and file study documentation in a timely manner.

Qualifications & Experiences

Profile

• Senior Clinical Trial Assistant with at least 5 years of experience in clinical research, supporting Clinical Project Managers, CTMs, and clinical project teams.
• Based in Lyon would be a strong advantage; being based in France is required due to regular travel to Lyon.
• Available to start mid-September 2026 and commit initially until the end of December 2026.
• Previous experience in an international clinical trial environment would be a plus.
• Experienced in TMF management and any documentation management related to clinical studies.
• Bachelor’s degree in life science.

Skills

• Strong knowledge of ICH-GCP and applicable regulations.
• Good knowledge of eTMF and CTMS systems.
• Very good oral and written communication skills.
• Ability to work both as part of a team and independently, with a high level of autonomy.
• Ability to provide high-quality deliverables with strong attention to detail.
• Proactive mindset and ability to propose initiatives to improve processes and good practices.
• Flexible, adaptable, and able to be quickly operational in a fast-paced clinical trial environment.