01 oct
|
CliniRx
|
Comunidad de Madrid
01 oct
CliniRx
Comunidad de Madrid
Were Hiring: TMF Specialists (2 Open Positions) 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 adecuado 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. * Additional languages are a plus. What We
📌 Trial Master Files Specialist (Comunidad de Madrid)
🏢 CliniRx
📍 Comunidad de Madrid