Trial Master File (TMF) Specialist III

At ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON's global 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.

Responsibilities

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 organisational skills, with the ability to manage multiple tasks simultaneously
• Excellent communication skills, with the ability to partnership effectively with cross-functional teams
• Willingness to travel as required (approximately 5%)

Rewards & Benefits

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.

Benefits may include:

• 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 wellbeing resources
• Learning and development opportunities through structured training and career pathways