Clinical Operations Study Country Lead (COSCL) at Sanofi Aventis US LLC

Tokyo, , Japan -

Full Time

Start Date

Immediate

Expiry Date

13 Jun, 26

Salary

0.0

Posted On

15 Mar, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical Operations, Study Country Lead, Project Management, Clinical Trial Oversight, Digital Technologies, AI-Driven Solutions, GCP, ICH Guidelines, Regulatory Requirements, Stakeholder Management, Budget Management, Data Analytics, Risk Escalation, Study Start-Up, Compliance, AI Ethics

Industry

Pharmaceutical Manufacturing

Description

Job title: Clinical Operations Study Country Lead (COSCL) Location: Tokyo, Japan About the job Our Team: We are seeking a highly motivated and experienced Clinical Operations Study Country Lead to support local clinical trial operations. The COSCL will be a strategic leader within the Clinical Study Unit (CSU), accountable for the planning, execution, and oversight of clinical trials from country allocation through study closure and archiving. This role ensures compliance with Sanofi SOPs, ICH/GCP, and local regulatory requirements, while leveraging AI-driven solutions to optimize processes. As the primary interface between the CSU and the global study team lead (COSL), the COSCL represents the country in global meetings, escalates risks, and owns country-level decisions to ensure successful study delivery. The role involves close collaboration with internal and external stakeholders to enhance operational efficiency and accelerate trial execution. The ideal candidate will possess a deep understanding of current digital technologies, AI applications, and direct experience implementing innovative solutions to deliver transformative approaches for enhancing clinical studies. Clinical Operations Study Country Lead （COSCL）は、Clinical Study Unit（CSU）における戦略的リーダーとして、国レベルでの臨床試験を計画・実行・監督する役割を担う。国への試験割り当てから試験終了・アーカイブまでの全プロセスに責任を持ち、Sanofi の SOP、ICH/GCP、国内規制を遵守し、AI を活用した効率化・品質向上を推進する。本ポジションは、CSU とグローバルスタディチームリード（COSL）との主要な窓口として、グローバル会議で国を代表し、リスクをエスカレーションし、国レベルの意思決定を担い、試験成功を支える。また、内部および外部ステークホルダーと緊密に連携し、オペレーション効率の向上と試験実施の迅速化に取り組む。最新のデジタル技術や AI 活用に関する深い理解を持ち、臨床試験をより良くするための変革的アプローチを実現する革新的なソリューションを実装した経験を有することが望ましい。 Clinical Operations Study Country Lead: · This person will lead the strategic and operational execution of clinical trials at the country level · Ensure alignment with global study objectives, Sanofi SOPs and local regulatory requirements while driving innovation through AI and digital transformation · Accountable for study delivery, end to end planning, compliance and performance · Key role in advancing Sanofi’s digital and AI-enabled clinical development strategy · Contribute to Sanofi’s commitment to accelerate the development of new drugs for all patients through our clinical trials Clinical Operations Study Country Lead は以下を担います： · 国レベルでの臨床試験の戦略的およびオペレーショナルな実行をリードする · グローバルの試験目標、Sanofi SOPや国内規制要件との整合性を確保しつつ、AI とデジタル変革によるイノベーションを推進する · 試験のエンドツーエンドの計画、遵守、パフォーマンスに責任を負う · Sanofi のデジタル／AI を活用した臨床開発戦略の推進において重要な役割を果たす · 臨床試験を通じ、すべての患者に対する新薬開発の加速という Sanofi のミッションに貢献する Main responsibilities: Clinical Operations Study Country Lead: · Lead strategic planning, execution and oversight of country clinical trials allocated, ensuring alignment with global strategy, timelines, budgets and local regulatory guidelines · Lead digital transformation by identifying, and implementing AI-driven solutions to enhance trial efficiency, site performance and patient engagement, and promote ethical AI use, data privacy and governance · Representing the country in global study meetings, escalate risks, make country-level decisions to support study success · Oversee study start-up activities, including feasibility, selection and recruitment strategies by leveraging digital tools and AI analytics to ensure site readiness and performance · Foster strong communication with internal teams, vendors and external partners, and lead stakeholder communication · Manage local study budgets, monitor financial performance and ensure data integrity, patient safety, audit readiness and quality oversight · Leverage data analytics to inform decisions, identify digital opportunities Clinical Operations Study Country Lead として · グローバル戦略、タイムライン、予算、国内規制に沿って、割り当てられた国の臨床試験の戦略立案、実行、監督をリードする · AI を活用したソリューションを特定・導入し、試験効率、サイトパフォーマンス、患者エンゲージメントを向上させ、倫理的な AI 活用、データプライバシー、ガバナンスを推進する · Global study meetingで国を代表し、リスクをエスカレーションし、試験成功を支える国レベルの意思決定を行う · デジタルツールや AI 分析を活用して、フィージビリティ、サイト選定、リクルート戦略を含む試験開始活動を監督し、サイトの準備性・パフォーマンスを確保する · 内部チーム、ベンダー、外部パートナーと効果的なコミュニケーションを構築し、ステークホルダー対応をリードする · ローカル試験予算を管理し、財務パフォーマンスをモニタリングし、データインテグリティ、患者安全性、監査対応、品質管理を確保する · データ分析を活用して意思決定を支援し、デジタル活用の機会を特定する About you · Experience in clinical study operation, including project management and clinical trial oversight · Preferred experience in assessing and implementing digital technologies in clinical study · Strong knowledge of GCP, ICH guidelines and local regulatory requirements · Digital literacy with hands-on experience in AI-powered tools and data analytics · Familiarity with machine learning in healthcare, and understanding of AI ethics and governance · Strong organizational and project management skills, including ability to multitask and organize/track information · Excellent written and verbal communication skills with strong stakeholder management · Ability to work independently and in a team environment · Business-level English. Ability to read/write documents, email communication, and participation in meetings in English · Ability and willingness to Travel nationally and internationally, depending on trial activities · 臨床試験業務の経験（プロジェクトマネジメントや臨床試験のオーバーサイト経験を含む） · 臨床試験におけるデジタル技術の評価・導入経験があることが望ましい · GCP、ICH ガイドライン、国内規制の強い理解 · AIツールやデータ分析などデジタル活用の実務経験 · ヘルスケア領域における機械学習の知識、および AI倫理・ガバナンスの理解 · 高い組織力・プロジェクトマネジメント能力（複数業務の同時進行、情報整理・トラッキングのスキル） · 卓越した文章・口頭でのコミュニケーション能力と強いステークホルダーマネジメント力 · 自立して働く力とチームで協働する力の両方 · ビジネスレベルの英語力（英語での文書作成、メール、会議参加が可能であること） · 試験状況により国内外への出張が可能であること Pursue progress, discover extraordinary Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com! Global Terms & Conditions and Data Privacy Statement Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions. With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting www.sanofi.com or via our movie We are Sanofi As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live. All in for Diversity, Equity and Inclusion at Sanofi - YouTube

Responsibilities

The Clinical Operations Study Country Lead is accountable for the strategic planning, execution, and oversight of country clinical trials, ensuring alignment with global strategy, timelines, and local regulatory guidelines. This role involves leading digital transformation by implementing AI-driven solutions to enhance trial efficiency and representing the country in global study meetings.