30 sep
|
CliniRx
|
Madrid
We're Hiring: TMF Specialists (2 Open Positions)
Obtenga más información sobre las tareas generales relacionadas con esta posibilidad a continuación, así como sobre las habilidades requeridas.
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. xiphteb
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
📌 Trial Master Files Specialist (Madrid)
🏢 CliniRx
📍 Madrid