Clinical Trial Manager
CL
PRA Health Sciences
Req #: 118938
Type: Chile
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Overview: As a Clinical Trial Manager you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence. You will be part of an innovative and global Biotechnology company, who pride themselves to be one of the world's leading independent biotechnology companies. They focus on areas with unmet medical need with the ambition to help reduce the social and economic burden of disease in society today. Responsibilities: What you will be doing: * Planning, management, and oversight of clinical study execution in accordance with the global program strategy, through leadership of the cross-functional Local Study Team (LST). * Contributes and develops to program/study-specific materials - e.g., monitoring plan, study specific training documents. * Accountable for site-level goal setting and study-specific deliverables for clinical sites within their country/-ies. * Contributes to, deliver and/or lead CRA, Investigator and Study Coordinator training. * Provides oversight and monitoring of applicable vendor activities e.g., laboratories and equipment provisioning. * Provides country level input into the Country Operational Plan (COP) and partner with the DFM through feasibility and with the GCMs to ensure local delivery of the study. * Responsible for approval of Baseline and Revised Enrolment Plans (Country Level). * Monitors the execution of the clinical study against timelines, deliverables, and budget for that country. * Translates global start up requirements into local country targets * Monitors and acts upon data flow metrics - review, trend identification and analysis, with targeted follow up where appropriate. * Identifies and facilitates resolution of cross-functional study-specific issues. * Escalates any issues related to delivery, timelines, or budget to GCMs (or TMT le ad if appropriate). * Executes regulatory agency inspection readiness activities (e.g., TMF review, story board generation). * Collaborates with local teams to ensure country level study delivery is aligned with global expectations. * Identifies risk, implementing risk mitigation strategies, and resolving issues at a country/site level, as well as informing the CST / TMT, LST and local teams of risks associated with delivery in a proactivetimely and solution orientated manner. Qualifications: You are: * Bachelor's degree in a health, life sciences, or other relevant field of study. * Minimum 5-6 years' work experience in clinical research or/ knowledge in Project Management and Site Management * CRA Experience preferred 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. 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.
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