23 oct
|
Alten Spain
|
Madrid
23 oct
Alten Spain
Madrid
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 #J-18808-Ljbffr
📌 Tmf Specialist (Madrid)
🏢 Alten Spain
📍 Madrid