TMF Quality Review Jr. Associate

About the role

ICON Strategic Solutions is hiring a TMF Quality Review Jr. Associate for a home-based position in Mexico City. Working in a sponsor-dedicated model, you will help manage Trial Master File (TMF) documentation for clinical trials, supporting client service contracts and internal business needs.

Key responsibilities

• Take responsibility for TMF management deliverables, ensuring quality and efficiency
• Manage TMF documentation according to client requirements and ICON procedures
• Keep TMF documentation complete, accurate and timely throughout the clinical trial lifecycle
• Partner with cross-functional teams to collect, review and maintain documents needed for regulatory submissions
• Carry out quality checks and audits of TMF documents against regulatory standards and sponsor requirements
• Support internal and external stakeholders with TMF-related information and guidance

Required profile

• Minimum of 3 years of experience in clinical research or document management in the pharmaceutical, biotechnology or CRO industry
• Bachelor's degree in life sciences, documentation management or a related field (a Bachelor's degree in a relevant field is preferred)
• Legal right to work in the country where the role is based
• Willingness to travel approximately 5% of the time

Required skills

• Strong attention to detail and organizational skills, able to handle multiple tasks at once
• Excellent communication skills and effective collaboration with cross-functional teams

What we offer

• Competitive base salary and performance-related incentives
• Health and wellbeing programmes, including medical, dental and vision coverage where applicable
• Retirement and pension plans, life assurance and disability coverage
• Employee assistance programmes and learning and development opportunities