As a Senior CTA you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. The Clinical Trial Associate (CTA) supports the SSO Study Start-Up Manager and the SSO Clinical Project Manager with assigned studies during set-up and the whole study lifecycle in compliance with processes, GCP/ICH and regulatory requirements. **What you will be doing:** + Supports document collection, preparation, and adaption for submission to IRB/EC and Health Authorities, as applicable. + Sets up systems. + Supports vendor selection, TPRM process, SIM entries. + IF and TMF management (country and site TMF); set-up and maintenance according to regulatory and sponsor requirements; document oversight and tracking. + Supports vendor set-up as applicable. + Checks site “Green Light” completeness and ensures all documentation is in place for initial and subsequent drug release in collaboration with the local Qualified Person(s). + Supports preparation and translation of ICF to local languages (including vendor management, if necessary). + Supports preparation of patient facing material. + Responsible for completeness of uploaded trial-related documents into CREDI/SUBWAY, including archiving of paper TMFs. + Supports country SSU strategy in close collaboration with the SSU Team Lead and SSU Managers to ensure SSU timelines and deliverables are met according to country commitments. + Ensures adherence to financial standards, prevailing legislation, ICH/GCP, IRB/IEC, Health Authority and SOP requirements. + Provides logistic support to SSU CRA, CRA, CPM, SSU Manager during all phases of the clinical trial. + Implements innovative and efficient processes which are aligned with sponsor strategy. + Externally facing role with impact on Principal Investigators and Institution/Site business offices. + External engagements with vendor partners to lead site issue resolution as needed. + Partners with execution Clinical Research Associate to ensure seamless transition of site responsibility at time of site initiation. **You are:** + Advanced degree in a relevant field such as life sciences, clinical research, or a related discipline preferred. + 2+ years of experience in clinical trial management, with a strong understanding of clinical trial processes and regulatory requirements. + Proven ability to manage multiple projects effectively, with strong organizational and problem-solving skills. + Excellent communication and interpersonal skills, with the ability to collaborate effectively with diverse teams and stakeholders. + Detail-oriented with a proactive approach to ensuring trial success and addressing clinical challenges. **What ICON can offer you:** Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional 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 maximise 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 Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below. https://careers.iconplc.com/reasonable-accommodations Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.