Clinical Trial Assistant

Roles & Responsibilities
• Support global clinical study teams in oncology, cardiology, pulmonology, and immunology trials
• Maintain and manage Trial Master File (TMF) documentation ensuring completeness and compliance
• Upload, review, and track essential documents in Veeva Vault
• Manage study information in CTMS and EDC systems
• Assist in study start-up activities including site document collection and tracking
• Track regulatory submissions, approvals, and essential document timelines
• Coordinate internal and external meetings, prepare minutes, and maintain training documentation
• Support cross-functional communication between sponsors, CRO teams, vendors, and investigational sites
• Monitor study milestones, key performance indicators (KPIs), and trial metrics
• Ensure documentation is audit-ready and inspection compliant
• Assist in preparation for audits and regulatory inspections
• Maintain version control and document archival processes
• Ensure adherence to ICH-GCP and applicable regulatory requirements
• Provide administrative and operational support to Clinical Project Managers and CRAs

Qualification
• Bachelor’s degree in Life Sciences, Pharmacy, Biotechnology, or related field
• CTT certification (preferred / as applicable)
• Bachelor of Pharmacy, Master of Pharmacy

Experience
• 1–2 years of experience as a Clinical Trial Assistant in global clinical trials
• Experience working in oncology or other complex therapeutic areas preferred
• Hands-on experience with Veeva Vault, CTMS, and EDC systems

Skills
• Strong understanding of clinical trial processes and ICH-GCP guidelines
• Proficiency in Veeva Vault, CTMS, and EDC platforms
• Excellent documentation and organizational skills
• Strong attention to detail and compliance mindset
• Effective communication and cross-functional coordination skills
• Ability to manage multiple priorities in a structured, fast-paced environment
• Strong time management and deadline adherence
• Proficiency in MS Office applications

About the Organization
ICON plc is a global healthcare intelligence and clinical research organization supporting pharmaceutical, biotechnology, and medical device companies in clinical development. Known for innovation, operational excellence, and a strong commitment to diversity and inclusion, ICON provides dynamic career
growth opportunities within a structured and high-performance environment.