Site Specialist Ii

Site Specialist II - Hybrid Mexico CityICON 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 SpecialistLocation: Mexico City - Insurgentes Sur(Hybrid model 3 days peer week working at office - 2 days from home)What you will be doing:- Proficient knowledge of ICON SOPs/WPs, ICH/GCP and applicable country regulations/guidelines and ICON systems.- Support Site Partners to collect, review, organize and assemble initial start-up and maintenance submission packages to Central EC/IRB, Local EC/IRB, Competent Authorities, any other local regulatory authorities as required by countries and in accordance with ICH/GCP and applicable country regulations/guidelines.- Support collection and assembling of all documents needed in the Critical Document Package (CDP) and/or those required for site activation, ensuring that Sponsor and Investigator obligations are being met and are in compliance with applicable requirements and ICH/GCP guidelines.- Support coordination of all necessary translations required for any start-up documentation.- Perform timely and accurate progress data entry of all documents collected from sites and of the relevant study site activation activities into the appropriate tracking systems and tools.- Participate to internal study review meetings with study teams to provide updates on site progress in document collection and on the executed site activation tasks.- Accurately forecast Site Activation plans and ensure that they are reflected accurately in ICON’s systems and proactively follow through for achievement to plan.- 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.- Attend study team meetings as requiredYour profile- Bachelor’s Degree completed preferably in Life Sciences- Minimum of 2 -4 years’ experience or understanding of clinical study start up requirements and activities. (USA sites as preference)- Knowledge of local and/or international regulatory processes, including submissions to regulatory authorities and ethics committees.- Previous experience using CTMS, goBalto, Veeva Vault, TMFs, etc.- Ability to read and understand clinical protocols, regulatory documents, and study-specific processes.- Strong attention to detail and organizational skills.- Ability to work independently and manage multiple tasks simultaneously in a fast-paced environment.- Excellent communication skills both in EnglishLI-DG1LI-HybridWhat 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.