As a Manager, Study Start Up you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. **What you will be doing:** + Working directly with Investigative Sites, this role will independently manage and perform activities at a site level associated with study start-up including regulatory document collection, preparation of ethics submission documents, informed consent review and essential document package review. + Must have an in-depth understanding of study start-up activities and associated regulatory requirements. **You are:** + Bachelor’s degree with a major in a related field (or equivalent experience) and at least 5 years of experience in study start-up In-depth knowledge of start-up processes and procedures + Must have good working knowledge of ICH, FDA, IRB/IEC and other applicable regulations/guidelines + Experience with investigative site start-up documents + Good understanding of clinical trial execution **Key Competencies Required** + Ability to work under pressure to meet deadlines + Self-motivated and ability to work well independently and in a team environment + Ability to effectively manage multiple priorities + Excellent verbal and written communication + Excellent project management skills + Excellent collaboration skills + Meticulous attention to detail and process-oriented **In addition to experience listed above:** + Minimum of 8 years prior experience within a clinical role – for example Clinical Operations, Study Start Up, Clinical Team Manager - Highly preferred + Undergraduate degree (or its international equivalent - Or equivalent related industry experience) in clinical, science or health-related field from an accredited institution **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 At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we’ve done to become a more inclusive organisation. 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, 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. 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.