Manager, Study Start Up
PRA Health Sciences
Req #: 113494
Type: Denmark
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Overview: As a Study Start Up Manager you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence. In this role, you will work directly with Investigative Sites, managing and performing 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. You must have an in‐depth understanding of study start‐up activities and associated regulatory requirements. Responsibilities: In this role, you will: * Build and cultivate relationships with key study personnel, including Study Coordinators * Work directly with Investigative Sites for all aspects of study start‐up including: activation timeline development, regulatory document preparation and collection, assisting with IRB/EC submissions and informed consent review * Assist in creation, review and customization of country/site specific Informed Consent Forms (ICFs) * Assist in drafting and responding to IRB queries and facilitating responses to EC queries * Assist in contract and budget negotiations, as necessary * Manage translations of relevant study documents * Proactively identify site challenges and implement appropriate mitigations * Provide regular local status updates to study team and escalated risks to timelines * Manage and track issues and escalations to internal stakeholders * Assist in the development of start‐up plans * Update study‐tracking tools and databases with site status * May participate in feasibility and/or site identification activities * Performs other duties as assigned Qualifications: You will need: * Bachelor's degree with a major in a related field and at least 5 years of experience in study start‐up In‐depth knowledge of start‐up processes and procedures * A solid understanding of key regulatory authorities and regulatory 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.
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