[Hiring] Senior Clinical Trial Associate @ICON plc

Role Description

We are currently seeking a Senior Clinical Trial Assistant (CTA) to join our diverse and dynamic team. As a Senior CTA at ICON Plc, you will play a key role in supporting the management and execution of clinical trials by handling a range of administrative and operational tasks. You will contribute to the smooth execution of clinical trials through efficient coordination, documentation, and communication with various stakeholders.

• Assist in the preparation and maintenance of essential study documents, including study protocols, informed consent forms, case report forms (CRFs), and other trial-related materials.
• Collaborate with cross-functional teams to ensure accurate and timely completion of study start-up activities, such as site selection, feasibility assessments, and ethics committee submissions.
• Support the organization and conduct of investigator meetings, study initiation visits, and other trial-related meetings.
• Coordinate and track the distribution, collection, and reconciliation of trial supplies, investigational products, and study-related materials.
• Assist in the review and resolution of data queries, ensuring data accuracy and completeness within electronic data capture (EDC) systems.
• In collaboration with TMF Operations team, maintain trial master files (TMFs) and study documentation in accordance with regulatory requirements and internal SOPs.
• Facilitate effective communication among study team members, investigators, and study site personnel through regular correspondence and timely dissemination of study-related information.
• Support the monitoring and tracking of study progress, including patient recruitment and enrollment, to ensure adherence to study timelines and milestones.
• In collaboration with other Clinical Operations groups (Site Engagement and Monitoring Excellence), assist, as necessary, in the preparation and coordination of site monitoring visits, ensuring compliance with monitoring plans and resolution of site-related issues.
• Stay updated with relevant regulations, guidelines, and industry best practices pertaining to oncology clinical trials, ensuring compliance, and implementing necessary changes as required.

Qualifications

• Singapore Citizen or Permanent Resident
• 3+ years of CRO or Pharma Clinical Trial Associate, Clinical Trial Assistant, In-house CRA or Site Management Associate experience including Global SIT Oncology and clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
• Knowledge of clinical trial regulations, guidelines, and best practices, including ICH-GCP.
• Bachelor's degree.
• Fluent English.
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Project).

Benefits

• 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.