Clinical Trial Assistant, TMF

ICON plc is a healthcare intelligence and clinical research organization seeking a Clinical Trial Assistant (CTA) to support Trial Master File (TMF) operations. The role focuses on hands-on eTMF quality control, documentation quality oversight, and ensuring TMF accuracy, consistency, and compliance to support inspection readiness and trial execution.

• Provide administrative support for clinical trials, including managing documentation, coordinating meetings, and maintaining trial-related records.
• Assist with preparation and submission of regulatory documents and ensure compliance with study protocols and regulatory requirements.
• Collaborate with cross-functional teams to support trial operations and help resolve study issues.
• Monitor and track trial progress, manage site communications, and support timely delivery of study materials.
• Build and maintain relationships with site staff and other stakeholders to support smooth trial operations.
• Perform hands-on eTMF QC reviews, assessing TMF content accuracy, completeness, and compliance across TMF sections.
• Evaluate cross-document relationships and alignment to ensure consistency and integrity and support inspection readiness.

• Bachelor’s degree or relevant certification in life sciences, healthcare, or clinical research (highly preferred).
• Extensive experience in a clinical trial support role with understanding of clinical trial processes and regulatory requirements.
• Strong organizational and multitasking skills with ability to manage multiple tasks and projects.
• Proficiency in clinical trial management systems and relevant software; strong attention to detail in documentation and data management.
• Excellent communication, interpersonal, and problem-solving skills; ability to work collaboratively with diverse teams and stakeholders.
• Demonstrated experience performing hands-on eTMF/TMF QC reviews beyond basic administrative checks.
• Strong knowledge of TMF structure, regulatory expectations, and cross-document consistency requirements; ability to identify gaps, discrepancies, and quality risks.

• Competitive salary (amount not specified) plus benefits.
• Benefits may include annual leave entitlements, health insurance options, retirement planning, employee assistance program (LifeWorks) with 24/7 access, life assurance, and country-specific optional benefits (e.g., childcare vouchers, bike schemes, discounted gym memberships, subsidized travel passes, health assessments).
• Inclusive workplace and accommodations available for candidates with medical conditions or disabilities.