Clinical Trial Assistant
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- 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.
- Travel to Lyon occasional
- 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.
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