10 oct
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Ciudad de México
10 oct
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Ciudad de México
Home Based - Mexico - TMFAt ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON’s general expertise.
As the world’s largest FSP organisation, with over 90 sponsor partnerships, we offer stability, career development and a collaborative environment where your work contributes to the development of treatments that benefit patients worldwide.
As a Trial Master File (TMF) Specialist III at ICON, you will participate in client services contracts and internal business needs by managing Trial Master File (TMF) documentation.
What You Will Do:
You will take responsibility for trial master file management deliverables, applying your skills to ensure quality and efficiency.
Key responsibilities include:
• Manage Trial Master File (TMF) documentation in accordance with client requirements and ICON procedures
• Ensure the completeness, accuracy, and timeliness of TMF documentation throughout the lifecycle of clinical trials
• Partnership with cross-functional teams to collect, review, and maintain essential documents for regulatory submissions
• Conduct quality checks and audits of TMF documents to ensure compliance with regulatory standards and sponsor requirements
• Provide efforts and guidance to internal and external stakeholders on TMF-related matters
Your Profile:
You will bring relevant trial master file management experience, along with the following qualifications and skills.
Required qualifications and experience:
• A minimum of 3 years of experience in clinical research or document management within the pharmaceutical, biotechnology, or CRO industry
• Bachelor's degree in life sciences, documentation management, or a related discipline
• Strong attention to detail and organizational skills, with the ability to manage multiple tasks simultaneously
• Excellent communication skills, with the ability to partnership effectively with cross-functional teams
• Bachelor's degree in a relevant field preferred
• Willingness to travel as
📌 TMF Quality Review Jr. Associate (Ciudad de México)
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📍 Ciudad de México