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. The role of the Clinical Operations Manager/Start Up Lead is responsable for performance and compliance for assigned protocols in Italy with ICH/GCP and country regulations, policies and procedures, quality standards and adverse event reporting requirements internally and externally. Key responsibilities include: Execute and oversee clinical trial country submissions and approvals Develops local language materials including language Informed Consents and translations. Interact with IRB/IEC and Regulatory Authority Supports country deliverables, timelines and results to meet country commitments Responsible for quality and compliance Contribute to the development of local SOPs Coordinate s and liaise s with CRM, CTC, CRA to ensure country deliverables are obtained Collaborate closely with the headquarter to align country timelines Provide support and oversight to local vendors Oversee and coordinate local processes, clinical and ancillary supplies management, importing and exporting requirements, supplies destruction, local electronic/hard copy filling, archiving and retention requirements, and insurance process management Clinical Supply and non-clinical supply management Mana ge s Labelling requirements and proper destraction of clinical supplies You Are : 1-2 years of experience in clinical research Associate Degree or equivalent Health Care related xperience is r equired, Bachelor's Degree is a plus Expertise of core clinical systems, tools and metrics Strong coordination and organizational skills Basic knowledge of budget and contract negotiations, local regulatory environment and submission and approval processes, and understanding of how these impact study start-up Fluency in Italy and professional proficiency in English. We believe our Clinical Operations team is second to none. You will receive the support you need to develop personally and professionally and work in an environment where you matter. Our team pushes forward together. United in solving problems, developing close site relationships and reaching the end goal. Operating as a key part of a global study team, the CRA plays a fundamental role in our clients' drug development processes. 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. 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 maximise 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 our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits ICON, including subsidiaries, 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, 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 or submit a request here . 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.
