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
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📌 Trial Master Files Specialist (Comunidad de Madrid)
🏢 CliniRx
📍 Comunidad de Madrid
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