? We're Hiring: TMF Specialists (2 Open Positions)

? Employment Type: Full-time

? Language Requirement: Fluent English

? About the Role

We are looking for two detail-oriented TMF Specialists to join our growing Clinical Operations team.

As a TMF Specialist, you will play a key role in ensuring that Trial Master Files (TMFs) are complete, accurate, inspection-ready, and maintained in compliance with GCP and regulatory requirements. This position is idóneo for professionals with approximately 2 years of experience in clinical research documentation or TMF management who are looking to grow within an international environment.

? Key Responsibilities

- 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.

? ?? ? Requirements ? Education




- 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

? Skills
- 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.

?️ Languages
- 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

? Apply Now If you have 2+ years of experience in TMF management or clinical research documentation , are passionate about quality and compliance, and want to contribute to the success of global clinical trials, we'd love to hear from you!

? Please submit your CV in English to [email protected]

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