About the Role
We are looking for two detail-oriented TMF Specialists to join our growing Clinical Operations team.
* Manage and maintain electronic Trial Master Files (eTMF) throughout the study lifecycle.
* Review, classify, and file essential clinical trial documents.
* Conduct TMF quality checks and completeness reviews.
* Track missing or overdue documents and follow up with study teams.
* Support TMF reconciliation activities and inspection readiness.
* Collaborate with Clinical Operations, Regulatory Affairs, Quality Assurance, and external partners.
* Generate TMF metrics, reports, and study documentation status updates.
* Assist during audits and regulatory inspections.
* Contribute to continuous improvement initiatives and TMF best practices.
* Bachelor's degree in Life Sciences, Pharmacy, Biology, Health Sciences, or a related field. Experience
* Approximately 2 years of experience in:
* TMF Management
* Clinical Operations
* Clinical Research
* Document Management within the Life Sciences industry
* Good understanding of ICH-GCP and clinical trial documentation.
* Experience with eTMF platforms
* Excellent organizational and documentation skills.
* Strong attention to detail.
* Ability to manage multiple priorities in a fast-paced environment.
* Strong communication and stakeholder management abilities.
* Fluent English (written and spoken) is required.
* Additional languages are a plus.
What We Offer
* Competitive salary package
* International and multicultural work environment
* Ongoing learning and professional development opportunities
* Career growth within Clinical Research and Clinical Operations
* Collaborative and supportive team culture
📌 Trial Master Files Specialist (Madrid)
🏢 CliniRx
📍 Madrid
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