? 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 ideal 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 integral clinical trials, we'd love to hear from you!

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

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