Study Review Specialist I

hace 3 días

Ciudad de México ICON Plc A tiempo completo

Study Review Specialist I - Mexico City onlyICON 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 developmentStudy Review Specialist ILocation: Mexico (_Office Based in Mexico City only_)As a _Study Review Specialist I_ you will be responsible for reviewing and approve global Critical Package Documents (CDPs) prior to IP release in accordance with ICON SOPs/WPs, Sponsor SOPs, applicable country regulations/guidelines and the principles of ICH/GCP, ensuring the highest quality and accuracy of documentation.What You Will Be Doing:Perform timely and accurate task progress communication and data entry of all relevant CDP Review and Approval activities into the appropriate tracking system.- Ensure CDP approval dates are reflected accurately in ICON’s systems and are achieved in the required turnaround timelines- Conduct internal quality review of packs (parallel reviews) or TMF, where assigned.- Work with key stakeholders to optimize performance and collaborate to ensure successful project outcomes- Assume responsibility as Subject Matter Expert (SME) for the required topics, ensuring knowledgeable and updated in any changing regulatory requirements.- Attending study team meetings as required- Support other teams across VAST with additional tasks, where requiredWhat you need to succeed in the role:- Bachelor’s Degree preferably in Life Sciences- Fluency in English is a MUST (reading, writing, speaking)- Minimum of 1 years’ experience and understanding of Site Regulatory Package / Critical Package Documents (CDPs) requirements and activities.- Knowledge of local and/or international regulatory processes, including submissions to regulatory authorities and ethics committees.- 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.LI-ED1LI-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.

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