01 oct
|
CliniRx
|
Madrid
? We're Hiring: TMF Specialists (2 Open Positions)
?Employment Type:Full-time
?Language Requirement:Fluent English
? About the Role
We are looking fortwo detail-oriented TMF Specialiststo 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 approximately2 years of experiencein 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
Approximately2 years of experiencein:
TMF Management
Clinical Operations
Clinical Research
Document Management within the Life Sciences industry
? Skills
Good understanding ofICH-GCPand 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 have2+ years of experience in TMF management or clinical research documentation, are passionate about quality and compliance, and want to contribute to the success of general clinical trials, we'd love to hear from you!
?Please submit your CV in English to ******
📌 Trial Master Files Specialist (Madrid)
🏢 CliniRx
📍 Madrid