05 oct
|
CliniRx
|
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
📌 Trial Master Files Specialist (Madrid)
🏢 CliniRx
📍 Madrid