? 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 adecuado 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.
- Addit

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