Site Specialist Ii

Site Specialist II - RemoteICON 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 developmentSite Specialist II- Mexico - Remote_What you will be doing:- Work with Site Partners and internal key stakeholders to optimize study performance and collaborate to ensure successful site activation and project outcomes.- Support Site Partners on complex or on program of studies to proficiently collect, review, organize and assemble initial start-up documentation, system, training and equipment verifications as required by countries and in accordance with ICH/GCP, Site Activation Requirements and applicable country regulations/guidelines.- Support collection and assembling of all documents, system, training and equipment verification needed for site activation, ensuring that Sponsor and Investigator obligations are met and are in compliance with applicable requirements and ICH/GCP guidelines.- Ensure accuracy and completeness of the Site Activation Requirements via Task Completion in the Firecrest system.- Support coordination of all necessary translations required for any start-up documentation.- Accurately forecast, and maintain Site Activation plans and ensure they are reflected accurately in ICON’s systems, proactively follow through for achievement to plan.- Contribute to effective site activation process and timelines: participate to internal study review meetings with study teams to contribute and support risk identification to site activation, mitigation and action planning.- Ensure accuracy and timely completeness of Trial Master File (TMF) documents submitted during start-up and perform a Quality Control (QC) review of files before transfer to maintenance for filing in TMF.Your profile- Bachelor's degree in life sciences or a related field.- Previous experience in clinical research or regulatory affairs preferred, but not required.- Strong attention to detail and organizational skills.- Advanced English- Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams.- Ability to work independently and manage multiple tasks simultaneously in a fast-paced environmentLI-DG1LI-RemoteWhat 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 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.Visit ourcareers siteto read more about the benefits ICON offers.