Senior Study Start Up Associate (Regulatory Submissions) Chile - Hybrid Scheme
ICON 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 development.
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.
The Role: As a Senior Study Start Up Associate at ICON, you'll work within a large-scale, fast-paced environment assisting the Study Start Up Team Lead in the development of the plan for country and site distribution and execution of SSU activities in assigned countries.
Responsible for performing feasibility, site identification, site contract negotiation, and other SSU activities.Provide country specific SSU expertise to Study Start Up team leads and project teams.Responsible for the preparation and coordination of submissions to regulatory, ethics, and other bodies.Develop, finalize, and review Master and Country Specific Subject Information Sheets/Informed Consent Forms.What you need: A Bachelor's Degree or local equivalent and/or appropriate experience from the Medical/science background and/or discipline.+3.5 years of experience or understanding of clinical study start up requirements and activities.Strong understanding of regulatory requirements and guidelines for clinical trials, including ICH-GCP and local regulatory requirements.Excellent organizational and project management skills, with the ability to prioritize and manage multiple tasks simultaneously.Fluency in the local language and English is essential.Benefits 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. Our annual bonuses reflect delivery of performance goals – both ours and yours. 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 years ahead.
ICON is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, 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.
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