# SMA II **Company**: ICON Strategic Solutions **Location**: Mexico City **Work arrangement**: hybrid **Experience**: senior **Job type**: full-time **Category**: Healthcare **Industry**: Healthcare **Apply**: https://icon.wd3.myworkdayjobs.com/en-US/broadbean_external/job/Mexico-Mexico-City/Site-Management-Associate-I_JR152438?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply **Canonical**: https://yubhub.co/jobs/job_6c8c33a3-380 ## Description At ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON's global expertise. As the world's largest FSP organisation, with over 90 sponsor partnerships, we offer stability, career development and a collaborative environment where your work contributes to the development of treatments that benefit patients worldwide. As a SMA II at ICON, you will support the management and monitor of clinical trial sites by ensuring compliance with study protocols, regulatory requirements, and Good Clinical Practice (GCP) guidelines. **What You Will Do** You will contribute to clinical research activities, taking ownership of key CTA deliverables while collaborating closely with cross-functional teams. **Key Responsibilities:** - Providing advanced administrative and operational support to clinical trial teams across study start-up, maintenance, and close-out activities. - Managing and maintaining Trial Master File (TMF) documentation, ensuring completeness, accuracy, and inspection readiness in compliance with GCP and regulatory requirements. - Supporting site activation activities, including collection, review, and tracking of essential regulatory documents. - Acting as a key point of contact for internal stakeholders, sites, and vendors to ensure effective communication and coordination throughout the study lifecycle. - Tracking study progress, site metrics, and deliverables, proactively identifying risks or delays and supporting resolution. - Coordinating study-related logistics such as investigator payments, supplies, and document workflows. - Assisting with audit and inspection readiness activities, ensuring documentation is complete and compliant. - Supporting contract and budget tracking activities in collaboration with relevant teams. - Mentoring or providing guidance to junior CTAs or administrative staff, as applicable. **Your Profile** You will bring solid clinical research experience with a strong focus on clinical trial administration, along with the following qualifications and skills. **Required Qualifications and Experience:** - Bachelor's degree in Life Sciences, Healthcare Administration, Clinical Research, or a related field. - 2+ years of experience in clinical research, with strong exposure to CTA responsibilities and TMF management. - Experience supporting global clinical trials and collaborating with cross-functional teams across multiple countries and regions. - Solid understanding of clinical trial processes, including study start-up, regulatory documentation, and site support activities. - Strong knowledge of GCP guidelines and applicable regulatory requirements. - Excellent organisational and time management skills, with the ability to manage multiple priorities in a fast-paced environment. - High attention to detail and strong documentation skills. - Strong communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams and external stakeholders. - Proactive mindset with strong problem-solving and risk identification capabilities. - Experience with clinical systems (e.g., eTMF, CTMS) and Microsoft Office tools is preferred. **Work Model:** - This role is office-based during the first four months to support onboarding, training, and team integration. - Following the initial onboarding period, the role will transition to a hybrid work model, with 3 days in the office and 2 days working from home each week. **Rewards & Benefits:** - Competitive base salary and performance-related incentives - Health and wellbeing programmes including medical, dental, and vision coverage where applicable - Retirement and pension plans - Life assurance and disability coverage - Employee assistance programmes and wellbeing resources - Learning and development opportunities through structured training and career pathways ## Skills ### Required - Clinical Research - CTA Responsibilities - TMF Management - GCP Guidelines - Regulatory Requirements - Life Sciences - Healthcare Administration ### Nice to have - eTMF - CTMS - Microsoft Office --- Source: [Apply at icon.wd3.myworkdayjobs.com](https://icon.wd3.myworkdayjobs.com/en-US/broadbean_external/job/Mexico-Mexico-City/Site-Management-Associate-I_JR152438?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)