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As a Trial Master File (TMF) Specialist II at ICON, you will ensure the accuracy and completeness of the Trial Master File (TMF) throughout the clinical trial process.
Job Responsibility:
Managing the quality and integrity of the TMF by ensuring timely and accurate document uploads and metadata management
Collaborating with cross-functional teams to identify and resolve discrepancies in TMF documentation
Conducting regular audits of the TMF to ensure compliance with regulatory requirements and internal procedures
Providing training and support to team members on TMF best practices and document management systems
Generating reports and metrics to track TMF status and provide insights for continuous improvement
Requirements:
Bachelor's degree in life sciences, healthcare, or a related field
2+ years of experience in clinical trial operations or document management, with a focus on Trial Master File processes
Strong attention to detail and organizational skills
Excellent communication and interpersonal skills
Proficiency in electronic document management systems and an understanding of regulatory requirements related to TMF
Willingness to travel as required (approximately 5%)
What we offer:
Various annual leave entitlements
A range of health insurance offerings
Competitive retirement planning offerings
Global Employee Assistance Programme, LifeWorks
Life assurance
Flexible country-specific optional benefits including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments