Study Start Up Associate at ICON plc

Seoul, , South Korea -

Full Time

Start Date

Immediate

Expiry Date

14 May, 26

Salary

0.0

Posted On

13 Feb, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory Document Preparation, Ethics Committee Submissions, Regulatory Agency Communications, Stakeholder Coordination, Record Management, Regulatory Guidance, Process Improvement, Study Start-Up, ICH-GCP, Project Management, Organizational Skills, Communication, Interpersonal Skills, IRB Submission

Industry

Biotechnology Research

Description

Study Start Up Associate II-Home Based-South Korea-ICON Strategic Solutions 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 We are currently seeking a Study Start Up Associate II to join our diverse and dynamic team. As a Study Start Up Associate II at ICON, you will play a pivotal role in leading the initiation of clinical trials, ensuring compliance with regulatory requirements, and contributing to the advancement of inNvative treatments and therapies. What you will be doing Leading the preparation and submission of regulatory documents, including clinical trial applications, ethics committee submissions, and regulatory agency communications. Coordinating and liaising with internal and external stakeholders to obtain necessary approvals and authorizations for study initiation. Managing and maintaining comprehensive and accurate records of regulatory submissions, approvals, and correspondence Providing guidance and support to study teams on regulatory requirements and best practices for study start-up activities. Participating in process improvement initiatives to streamline study start-up processes and enhance efficiency. Your profile Bachelor's degree in life sciences or a related field. Minimum of 2 years of experience in clinical research or regulatory affairs, with specific experience in study start-up 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. Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams. Initial and Amendment for IRB Submission Home-Based #LI-remote #LI-SO1 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 maximize 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 site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. 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 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. Are you a current ICON Employee? Please click here to apply ICON is an award-winning workplace that enables you to make a difference to patients’ lives by being part of a world-class clinical research organisation that helps deliver new medicines & medical devices that are benefitting patients worldwide. You are also part of a diverse company that cares about our world and is dedicated to conducting business more sustainably and supporting the communities in which we live. If you’re as driven as we are, join us. You’ll be working in a great environment, with some of the brightest and the friendliest people in the sector, and you’ll be helping shape an industry. Didn’t find the role you were looking for? Even if the perfect role isn’t available right now, we’re always excited to connect with talented individuals. Register to our Talent Community to receive updates on roles that align with your career goals.

Responsibilities

The Study Start Up Associate II will lead the preparation and submission of regulatory documents for clinical trials, including coordinating with internal and external stakeholders to secure necessary authorizations. This role also involves managing submission records and providing guidance to study teams on regulatory requirements for study initiation.