eTMF Specialist
New
E
ExcelyaClinical Research
Paris, Île-de-France, FranceFull-TimeMiddle
Salary not disclosed
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Job Details
- Languages
- Fluent English (written and spoken)
Requirements
- Bachelor’s or Master’s degree in Health Sciences, Life Sciences, or a related field.
- Strong experience in clinical trial documentation management.
- Hands-on experience with Veeva Vault TMF (mandatory).
- Strong understanding of the DIA TMF Reference Model.
- Experience with TMF metrics, KPIs, and dashboards.
- Strong knowledge of ICH/GCP guidelines and regulatory requirements.
- Understanding of clinical trial documentation lifecycle.
- Knowledge of cross-functional stakeholders (Clinical, QA, PV, Biometry, etc.).
- Fluent English (written and spoken).
Responsibilities
- Manage the end-to-end lifecycle of eTMFs, including setup, maintenance, and close-out for clinical studies.
- Perform regular quality control checks to ensure document completeness, accuracy, and compliance with regulatory standards.
- Monitor and track TMF metrics and KPIs to ensure inspection readiness.
- Review and approve TMF management plans for internal teams and CROs.
- Act as a Subject Matter Expert (SME), providing guidance and training on eTMF best practices.
- Develop, update, and maintain SOPs, templates, and processes related to TMF management.
- Serve as the main point of contact for eTMF-related queries, audits, and inspections.
- Ensure compliance of the eTMF system with validation and regulatory requirements.
- Manage user access, system updates, and migrations, and assess the impact of new system releases.
- Collaborate with IT teams to resolve system issues and support continuous improvement.
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