Site and SSU Specialist
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.
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, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized 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, subsidized 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
-
Tokyo Amazon Web Services (AWS) ￥2,000,000 - ￥2,800,000 per year+Japón Énterprise Support Team para apoyar al Business Operations Generalist. · +Genera informes diarios, semanales, mensuales y trimestrales usando conjuntos de datos existentes. Proporciona informes precisos ante solicitudes específicas del gerente. Reúne datos desde múltiples ...
-
Tokyo griddable ￥1,800,000 - ￥2,400,000 per yearそん 工 わ Salesforce ＆ toki wo tsukau oya ga no kyoukai ni atatteiruu sakusei plan wa, oya ga no ne ni aawete 3 syurui no plan wo yoyuu shite, risousu , gaidanshu, gijutsusappyou wo tukau mashita. Sono sakusei plan no operashon ni sekininwo utteiruu service deryubariichimuwa oya ga ...
-
Tokyo, Tokyo Avanade ￥2,000,000 - ￥2,800,000 per yearビジネス開発のマネージャーとして、あなたは顧客アカウントや地域におけるビジネスチャンスを評価し、発展させ、形作る計画を立てます。パートナーやアライアンスと緊密に連携し、ビジネスを成長させ、顧客の意思決定者との長期的な関係を築きます。さらに、内部チームと協力して、顧客のニーズに合ったソリューションを提供し、契約を交渉します。 · ...
-
Tokyo Van Cleef & Arpelsヴァン クリーフ&アーペル / Van Cleef & Arpels · 冒険小説家ジュール・ヴェルヌの作品の世界、フランスで最も有名なおとぎ話の華麗な世界、旧約聖書の「ノアの方舟」の世界・・・ 私達は、コレクションを通じてお客様を様々な世界にいざないます。 · ブティック内の在庫管理 -ブティック内の在庫の動向、および納入・搬出分の全てについて在庫管理を行う(納品、移動、予約、委託)。 · 現金に関する全ての手続きと保有状況の管理を行う。 · ...
-
Tokyo, Tokyo QIAGEN ￥2,000,000 - ￥2,800,000 per year+海外から配送される製品の荷受業務(開梱、検品、棚入れ、等)、又は、そのサポート 国内代理店への商品配送関連業務、又は、そのサポート 上記に付随する事務作業(メール対応、事務所業務、PC作業、電話応対) 倉庫管理業務、又は、そのサポート · + · +
-
Tokyo griddable ￥4,000,000 - ￥8,000,000 per year本ポジション(ビジネスオペレーションスペシャリスト)は、 · カスタマーサクセスの組織の円滑な運営を支援する業務に従事します。 · ...
-
Tokyo griddableEnablementのプロフェッショナルとして、ビジネス成果拡大と目標の達成を支援するために戦略的なEnablementプログラムを策定し、各種ステークホルダーと連携し、成果を出せる組織にするField Enablement Business Partnerを募集します。 · ...
-
東京 / Tokyo Moneytreeマネーツリーは2025年8月の三菱UFJ銀行(MUFG)グループ参画を受け、変革期にあります。組織が75名規模へと拡大する中、エンタープライズ営業からSaaSビジネスまでを横断的に捉え、データに基づいた経営判断を支える「ビジネス・オペレーション(経営企画)」の重要性が高まっています。本ポジションはFP&Aマネージャーと密に連携して中長期的な事業計画の策定を担うとともに、營業ディレクターの戦略的パートナーとしてフォーキャスト管理やインセンティブ設計を担うとともに全社のKPIプランニングを主導する「経営のエンジン」としての役割を持つことです。 ...
-
Tokyo, Japan Unravel CarbonWe are looking for a high-energy proactive and versatile Business Operations Associate to join our Japan team This is a generalist role ideal for someone early in their career who wants to grow fast by owning a wide variety of responsibilities across our GTM functions including m ...
-
Tokyo, Tokyo Nextrials, Inc. ￥4,200,000 - ￥8,400,000 per yearWe are currently seeking a Study Start Up Associate II to join our diverse and dynamic team. · ...
-
Tokyo ICON Strategic Solutions ￥12,000,000 - ￥15,000,000 per yearWe are currently seeking a Study Start Up Associate II to join our diverse and dynamic team. · Leading the preparation and submission of regulatory documents, · including clinical trial applications, ethics committee submissions, · and regulatory agency communications. · ...
-
Tokyo, Japan Crimson InteractiveWe are looking for candidates who would enjoy working in a challenging environment and interacting with professionals on an international level, · who have the enthusiasm and ambition to be part of a Client Servicing team that delivers high-quality services. · (Provide guidance a ...
-
Business Associate
1週間前
Tokyo, Japan Crimson InteractiveThe Business Associate - Client Experience is a highly responsible role that involves client interaction and requires continual learning and self-development. · ...
-
Operations Associate
2ヶ月前
Greater Tokyo Area Eucalyptus ￥2,500,000 - ￥5,000,000 per yearWe are looking for an Operations Associate to join our growing Operations team and help establish Eucalyptus as a trusted leader in Japan's health tech landscape. The successful candidate will develop and maintain supply plans, manage stock ordering cycles, and ensure reliable, h ...
-
Tokyo ICON Strategic Solutions ￥4,000,000 - ￥6,400,000 per yearWe're proud to foster an inclusive environment driving innovation and excellence, · 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 clin ...
-
Japan-Tokyo TransPerfect ￥7,000,000 - ￥15,000,000 per year+We are seeking a Business Development Associate to join our team in Tokyo. · The successful candidate will be responsible for developing new business opportunities and relationships with large companies across multiple industries. · Develop an excellent understanding of TransPer ...
-
Tokyo Rakuten ￥3,000,000 - ￥4,500,000 per yearRakuten Mobile seeks a Business Operation professional to build new service operation flows. · ...
-
Tokyo Capital GroupMain responsibilities: Overall activities to promote CG Funds (especially focusing on sales through NISA/DC); Advisor meetings and workshops: Planning and conducting workshops, role-playing sessions etc for Advisors who sell CG managed funds Distributer relations: Providing seaml ...
-
Tokyo, Tokyo Aether Semiconductors ￥2,000,000 - ￥3,200,000 per yearThis is a full-time, on-site role for a Business Development Manager based in Tokyo. The individual will develop and execute strategies to expand client relationships identify growth opportunities and drive revenue generation. · ...
-
Tokyo RakutenLorem ipsum dolor sit amet, · consectetur adipiscing elit. · Sed do eiusmod tempor incididunt ut labore et dolore magna aliqua.Ut enim ad minim veniam · Nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. · ...
-
Greater Tokyo Area BioLabsBioLabs is launching its new site in Tokyo, Japan, seeking an experienced Business Operations Director to launch and manage the strategic growth of this location. · ...
