Site and SSU Specialist - Tokyo - Client Office 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 Job Advert Posting 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 - 治験申請書、IRB提出資料、規制当局へのコミュニケーション文書など、規制関連文書の作成・提出を主導する - 治験開始に必要な承認・許可を得るため、社内外ステークホルダーとの調整および連携を行う - 規制当局への提出物、承認、関連文書の正確かつ包括的な記録を管理する - 規制要件および治験開始のベストプラクティスについて、スタディチームへ指導・サポートを提供する - 治験開始プロセスの効率化に向けた改善活動に参加し、業務の最適化を推進する 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. - ライフサイエンス関連分野の学士号 - 治験または薬事関連業務で 2 年以上の経験があり、とくに治験開始（Study Start-Up）業務の経験を有する方 - ICH-GCP および各国の規制要件など、治験に関する規制の深い理解 - 優れた組織力・プロジェクトマネジメント能力を持ち、複数タスクを同時に管理できること - クロスファンクショナルチームと効果的に協働できる、優れたコミュニケーション能力および対人スキル 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

Lead business development operations by managing metrics reporting and analytics, conducting opportunity research, and facilitating pipeline meetings to support federal government contracting growth objectives. Provide ad-hoc analysis and bid support...

Utilize AI tools to enhance productivity, design optimized art assets, prepare high-quality game art packages, and collaborate effectively with teams to maintain artistic vision within technical constraints.

Who We Are GrowthAssistant connects top marketing and operations talent with fast-growing companies that depend on great execution to scale. Founded in 2021 and named by Forbes as one of the best startups to work at, we're a permanently remote team that runs on integrity, proactive candor, and a bias toward action — and we prioritize the human experience in everything we do. We hire for skill and for heart, and we invest in our people for the long haul About the Role GrowthAssistant is looking for a strategic, hands-on People leader to own and scale our People Operations function. This role will lead core HR programs and processes across compensation, performance, employee relations, compliance, payroll, onboarding, and engagement, while serving as a trusted partner to leadership. This person will manage a small team and help ensure our globally distributed workforce has the people programs, systems, and support needed to thrive. Key Responsibilities: - Lead and develop the People Operations function, including management of a small team. - Partner with leadership on people strategy, organizational planning, retention, and employee relations. - Own core People programs, including compensation reviews, performance management, benefits, onboarding, and engagement initiatives. - Oversee HR systems, employee data, payroll coordination, leave administration, and compliance across U.S. and global teams. - Support managers through performance issues, sensitive employee matters, and employee development. - Build and improve scalable policies, processes, and resources that support a high-performing, globally distributed team. Qualifications: - 6+ years of progressive HR experience, including time in a senior People Operations, HRBP, or broader HR leadership role. - Experience handling employee relations and other sensitive people matters. - Experience owning compensation cycles, benefits administration, payroll, and compliance. - Strong working knowledge of U.S. employment practices; global or international team experience is strongly preferred. - Experience managing or mentoring others on a People team. - Familiarity with HR systems such as Rippling; compensation benchmarking tools like PAVE are a plus What You'll Bring - A people-first mindset paired with strong analytical and operational instincts. - High ownership and comfort driving programs forward independently. - Sound judgment and discretion when handling sensitive compensation, performance, or employee relations matters. - The ability to move between strategic thinking and detailed execution. - A track record of building scalable HR programs in a fast-growing environment. - Genuine care for and experience working with global talent. What We Offer: - Competitive salary and performance-based incentives. - Comprehensive benefits package, including health, dental, and vision insurance. - 401k w/ match - Flexible paid time off - Opportunities for professional growth and development. - A supportive and inclusive work environment. GrowthAssistant is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. All employment decisions are based on qualifications, merit, and business need.