Clinical Trial Assistant, TMF

ICON plc • Blue Bell, SD

1d

About The Position

Clinical Trial Assistant (CTA) ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development We are currently seeking a Clinical Trial Assistant (CTA) to join our diverse and dynamic team. In this role, you will play a key part in supporting Trial Master File (TMF) operations, with a strong focus on eTMF quality control and content integrity. You will contribute to inspection readiness and overall trial execution through hands-on TMF review, documentation quality oversight, and close collaboration with cross-functional study teams to ensure TMF accuracy, consistency, and compliance across clinical programs.

Requirements

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

Responsibilities

• Providing administrative support for clinical trials, including managing documentation, coordinating meetings, and maintaining trial-related records.
• Assisting in the preparation and submission of regulatory documents and ensuring compliance with study protocols and regulatory requirements.
• Collaborating with cross-functional teams to support trial operations and resolve any issues that arise during the course of the study.
• Monitoring and tracking trial progress, including managing site communications and ensuring timely delivery of study materials.
• Building and maintaining strong relationships with site staff and other stakeholders to facilitate smooth trial operations and support overall project success.
• Perform hands-on eTMF quality control (QC) reviews, including detailed assessment of TMF content accuracy, completeness, and compliance across individual sections
• Ensure cross-document consistency and integrity by evaluating relationships, correlations, and alignment across TMF components to support overall inspection readiness

Benefits

• Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
• Our benefits examples include:
• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs.
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being.
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level