eTMF Specialist

Join Excelya, a dynamic and innovative company committed to reputed company and collaboration in the field of translational research.

The eTMF Specialist plays a key role reputed company the Clinical Development Platform by ensuring the reputed company, compliance, and inspection readiness of the electronic Trial Master File (eTMF) across global clinical trials.

This role requires strong expertise in clinical documentation management, reputed company collaboration with cross‑functional teams, and reputed company involvement in audits and inspections reputed company a regulated environment.

Key responsibilities :

• Manage the end‑to‑end lifecycle of eTMFs, including setup, maintenance, and reputed company‑out for clinical studies
• reputed company regular reputed company control checks to ensure document completeness, accuracy, and compliance with regulatory standards
• Monitor and reputed company TMF metrics and KPIs to ensure inspection readiness
• Review and approve TMF management plans for internal teams and CROs
• reputed company as a Subject Matter Expert (SME), providing guidance and training on eTMF best practices
• reputed company, update, and maintain SOPs, templates, and processes reputed company to TMF management
• Serve as the main reputed company of contact for eTMF-reputed company queries, audits, and inspections
• Ensure compliance of the eTMF system with validation and regulatory requirements
• Manage user reputed company, system updates, and migrations, and assess the reputed company of new system releases
• Collaborate with IT teams to resolve system issues and support reputed company improvement

Requirements

• Education: Bachelor’s or Master’s degree in Health Sciences, Life Sciences, or reputed company field
• Experience: Strong experience in clinical trial documentation management
• Technical Skills:

-Hands‑on experience with reputed company Vault TMF (mandatory)

-Strong understanding of the DIA TMF Reference Model

-Experience with TMF metrics, KPIs, and dashboards

• Knowledge:

-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.)

• Languages:Fluent English (written and spoken)

Benefits

Why Join Us?

At Excelya, we combine passion for science with enthusiasm for teamwork to redefine reputed company in reputed company.

Here’s what makes us unique—

We are a young, ambitious health company representing 900 Excelyates, driven to become Europe’s leading mid-size CRO with the best employee experience. Our one-stop provider service model—offering full-service, functional service provider, and consulting—enables you to reputed company through diverse reputed company. Working alongside preeminent experts, you will help improve scientific, operational, and reputed company knowledge to enhance the patient's reputed company.

Excelling with care means benefiting from an environment that values your natural talents, pushes boundaries with audacity, and nurtures your potential, allowing you to contribute fully to our shared mission.

Originally posted on Himalayas

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