Job Description 試験成功のためクリニカルオペレーション領域全体のリソースマネジメント、ソーシング戦略の立案・実行、サプライヤーマネジメント、プロジェクト予算の計画立案管理、KPI管理を担っている部署(クリニカルビジネスマネジメント)において、この度、グローバルのオペレーション組織に新たに設けられたBusiness Analyst(BA)Roleを導入することとなりました。 本ポジションは、グローバルリーダーシップ及び各国と連携しながら、テクノロジーとデータを活用して臨床試験のオペレーションの変革を推進するとともに、生産性、品質、コンプライアンスの向上をリードする役割です。 日本の臨床開発業務におけるオペレーション上の課題に対し、Automation、データ分析、AIを活用したソリューションを構想し、導入から定着までをリードしていただきます。業務遂行にあたっては、既存のClinical Operations(CO)内のAIやAutomationに関するタスクフォースと密接に連携するとともに、将来的には研究開発本部全体で展開される関連イニシアチブとの協働も想定しています。さらに、グローバルチームや他国との連携を通じて、ローカルのソリューションの最適化や他国への展開を推進し、グローバルな業務にも貢献いただくことが期待されます。 現場の課題解決を通じて新たな価値を創出し、日本で得られた成果をグローバルへ発信・展開することに意欲のある方を募集します。 【ポジション/ジョブレベル/グレード】 シニアビジネスアナリスト(Sr. BA)/ P3 【期待される主な役割】 ・Clinical Operation領域のリーダーシップチーム及びグローバルチームと連携し、Automation、データ分析、AIを活用し高い価値を創出する。 ・課題の特定、要件整理、解決策の検討、実装、展開及び定着までを一貫してリードし、各ステークホルダーとの連携により、全体最適なソリューションを導入、展開する。 ・ICH GCP、社内ポリシー及び国内規制への準拠を確保し、必要に応じてCompliance、Legal、IT、外部ベンダーとの連携によりセキュリティ、プライバシー、品質を確保する。 【必須要件】 ・臨床開発業務経験及びライフサイエンス/ヘルスケア領域におけるデータ/アナリティクス、プロセス改善、テクノロジー活用による変革に関する業務における複数年の経験 ・社内外のステークホルダーと円滑に協業するためのコミュニケーションスキル ・ビジネスレベルでの英語力:海外の同僚やグローバルチームと議論し、業務上の課題解決や意思決定に主体的に貢献できるコミュニケーション能力 ・論理的に課題を整理し、解決策を提案・実行する能力 【望ましい要件】 ・クリニカルオペレーションまたは臨床試験プロセスに関する知識・経験 ・部門横断的な調整及びプロジェクトマネジメント経験 ・ICH GCP、品質、データプライバシー及び情報セキュリティの基本原則の理解 ・IT・Data Science部門とのシステム/データ連携、または外部ベンダーとの調整経験 【その他】 コアタイム無しフレックスタイムとなる(参照:コアタイム無しフレックスタイム制度規定) Required Skills: Artificial Intelligence (AI), Automation, Change Management,
Revolution Medicines is a global, commercial-state oncology company dedicated to discovering, developing and delivering innovative medicines for patients with RAS-addicted cancers. Leveraging its differentiated RAS(ON) tri-complex inhibitor platform, the company is advancing a broad, integrated portfolio
Executive Assistant & Strategic Operations Coordinator Are you passionate about driving strategic business initiatives while supporting senior leadership in a fast-paced, international environment? Are you excited to work for a global company making a meaningful impact in
Build our future together: At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Clinical Study Lead to join our Clinical Trial Management team, supporting our Japan operations in
Build our future together: At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Senior Clinical Study Lead to join our Clinical Trial Management team, supporting our global,
Executive Assistant & Strategic Operations Coordinator Are you passionate about driving strategic business initiatives while supporting senior leadership in a fast-paced, international environment? Are you excited to work for a global company making a meaningful impact in
About the job Responsible for project activities associated with monitoring functions of phase I through phase IV clinical research studies and Real World Evidence (RWE) studies, while continuing to develop knowledge of drug development process, International Council
Were the worlds leading consumer healthcare platform, supporting millions of patients across the US, Australia, the UK, Germany, Japan, Spain and Canada. Were driven by the belief that good health should last a lifetime, and that
Locations: Tokyo, Japan Categories: Clinical Safety Req ID: 12606 Our clinical operations activities are growing rapidly, and we are currently seeking a full-time, Associate Director, Clinical Safety to join our Clinical Safety Department in Tokyo, Japan. This position plays a key
embecta is a global medical device company with a 100-year legacy in insulin delivery and diabetes care. Driven by innovation, purpose, and a commitment to improving lives, we are expanding our portfolio of solutions to serve
At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to
At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through our
Role Summary The Hepatology Medical Science Liaison (MSL) is a field-based, non-promotional role supporting GSK’s clinical development activities in hepatology in Japan. This position is focused on supporting ongoing and planned clinical trials through high-quality scientific exchange with
Strategic Partner to the GM Serve as the GM’s right arm in refining Masimo Japan’s five-year strategy and shaping the future direction of the business. Act as a senior thought partner to the GM on business
General Medicine Medical Science Liaison Manager YOUR TASKS AND RESPONSIBILITIES: Primary Activities 1. Exchange and dissemination of scientific, educational, and research related information: The MSL plans, prepares and engages with KOLs as an information scientist and
Revolution Medicines is a global, commercial-state oncology company dedicated to discovering, developing and delivering innovative medicines for patients with RAS-addicted cancers. Leveraging its differentiated RAS(ON) tri-complex inhibitor platform, the company is advancing a broad, integrated portfolio
At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through our
Key Accountabilities Country Quality System management Lead the implementation and maintenance of GxP quality system with respective operation units, the continues quality system implementation for competencies and related Quality documentation of GxP area: medical, pharmacovigilance, regulatory and
Revolution Medicines is a global, commercial-state oncology company dedicated to discovering, developing and delivering innovative medicines for patients with RAS-addicted cancers. Leveraging its differentiated RAS(ON) tri-complex inhibitor platform, the company is advancing a broad, integrated portfolio
The Japan Project Head (JPH) would be responsible for overall Japan development strategy for vaccine project in alignment with Global project strategy as well as Sanofi R&D strategy and business objectives. The JPH is accountable for