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At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives.Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organisation that delivers excellence to our clients and to patients at every touch-point. In short, to be the partner of choice in drug development.That’s our vision. We’re driven by it. And we need talented people who share it.If you’re as driven as we are, join us. You’ll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you’ll be helping shape an industry.**Job Description**:- Recognize, exemplify and adhere to ICON's values which centre around excellence in execution, exceeding expectations, and enhancing relationships- As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs- *Travel (approximately 10%) domestic and/or international- *To possess a solid understanding and working knowledge of ICH GCP, appropriate regulations, relevant ICON SOPs, ICON internal tracking systems and client SOPs I client systems (when applicable)- *To be a primary lead in the set-up, with the set-up, organization and maintenance of clinical study documentation (e.g. Study Files etc.) and guidelines (as appropriate) including preparation for internal/external audits, final reconciliation and archivalTo assist in the processing of Home care worksheet and Data Clarification Forms i.e. log in, tracking, quality control as appropriate for the study- *To drive responsibility in the quality control audits of clinical study documentation (e.g. Study Files, etc.) to ensure study files are inspection ready at all times- *To take a lead role in the initiation and facilitation of ordering/dispatch and tracking of trial materials (e.g. lab supplies, drug supplies etc.) as appropriate with mínimal guidance- *To proactively facilitate project teams with trial progress tracking by updating the Clinical Trial Management systems, providing access to systems and addressing any discrepancies with mínimal supervision- To independently and proactively run, review and analyze study reports for accuracy and work with the project teams to ensure updates are completed correctly- To assist in verification and co-ordination of study related payments, if applicable- *To contact and serve as a contact for clinical sites for basic requests (e.g., enrollment updates, missing documentation, meeting arrangements, etc.)- To co-ordinate document translation, if required.. To serve as the primary lead in the coordination of meetings/attend the meetings, preparation activities and the generation of meeting agenda and minutes with mínimal to no supervision and regularly attend and contribute to project specific and departmental meetings- To be the primary lead in the production of slides, overheads, etc., as needed for project, departmental, client and/or business development presentations- To lead the coordination of various tracking reports including but not limited to team member tracking and training- To work in collaboration with internal and external colleagues to meet project objectives, timelines, and budgets, where appropriate- *To mentor and train new and less experienced Clinical Trial Assistants (CTAs), including identification of training needs- *To keep the AIS Global Study Manager informed of any issues within the Project Team which require attention- To serve as a leading contributor to the development of the File Management Plan- *To effectively anticipate the needs of the study team and require mínimal oversight/instruction from the AIS Global Study Manager for tasks- To proactively create study templates, tools, and tracking methods for the study teams- To demonstrate resourcefulness, make appropriate use of available technology and tools in seeking and implementing solutions- *To assist proactively in the set-up of trial systems during study start up- To maintain client and patient confidentiality- Other duties as assignedBenefits of Working in ICON:Our success depends on the quality of our people. That’s why we’ve made it a priority to build a culture that rewards high performance and nurtures talent.We offer very competitive salary packages. And to keep them competitive, we regularly benchmark them against our competitors.We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans - and related benefits such as life assurance - so you can save and plan with confidence for the yea
