Trial Master Files Specialist

CliniRx; Comunidad de Madrid; Presencial; EUR 32.000 - 52.000; Jornada completa

Descripción de la vacante

CliniRx in Madrid is seeking two detail-oriented TMF Specialists to join our Clinical Operations team. You will manage and maintain eTMF files across the study lifecycle and ensure documentation is complete and audit-ready.

Ideal candidates have about 2 years in TMF, clinical operations, or related fields, with strong English skills and a good grasp of ICH-GCP and eTMF platforms. Fluency in English is required; additional languages are a plus.

Formación

• Bachelor's degree in Life Sciences or related field.
• Approximately 2 years of TMF/clinical operations experience.
• Strong knowledge of ICH-GCP and trial documentation.
• Experience with electronic TMF (eTMF) platforms.
• Excellent organizational, documentation, and multitasking abilities with strong attention to detail.

Responsabilidades

• 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, QA, 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.

Conocimientos

TMF Management

Clinical Operations

Clinical Research

Document Management

ICH-GCP

eTMF platforms

Organizational skills

Attention to detail

Stakeholder management

Communication skills

English fluency

Additional languages

Educación

Bachelor's degree in Life Sciences / Pharmacy / Biology / Health Sciences

Descripción del empleo

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

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