Job Description Summary

臨床試験の現場を動かし、患者さんに届く医療のスピードと質を支える——このポジションは、その最前線で活躍できる役割です。SSO Associate Clinical Project Managerとして、あなたは担当国における臨床試験の計画から実行、クローズアウトまでをリードし、多様なステークホルダーと連携しながら、確実で高品質な試験運営を実現します。日々のオペレーションを通じて専門性を高め、グローバルチームの一員として成長しながら、革新的な医薬品を患者さんに届ける確かなインパクトを生み出せるポジションです。
Play a pivotal role at the heart of clinical trial delivery, where your work directly supports the timely and high‑quality development of innovative medicines for patients. As an SSO Associate Clinical Project Manager, you will lead country‑level execution of clinical studies from initiation through close‑out, working closely with cross‑functional and global teams. This role offers a unique opportunity to build strong project management expertise, collaborate in a global matrix environment, and make a tangible impact on how clinical trials are delivered every day.

 

Job Description

Key Responsibilities

• 担当国における臨床試験の計画から実行、クローズアウトまでを一貫してリードする
  Lead end‑to‑end execution of assigned clinical studies at the country level
• グローバルおよび国内の関係者と連携し、試験の進捗・課題・リスクを適切に管理する
  Collaborate with global and local stakeholders to manage study progress, risks, and issues
• 試験スケジュール、進捗、KPIを管理し、品質と納期の両立を確保する
  Manage timelines, progress, and key performance indicators to ensure quality and delivery
• 施設およびClinical Research Associateと連携し、被験者組み入れ目標の達成を推進する
  Drive patient recruitment performance in collaboration with sites and Clinical Research Associates
• データ品質および規制遵守を確保し、GCPおよび社内基準に沿った試験運営を行う
  Ensure data quality and regulatory compliance aligned with Good Clinical Practice and internal standards
• モニタリング結果をレビューし、課題の是正およびエスカレーションを適切に実施する
  Review monitoring outputs and drive timely issue resolution and escalation
• 監査・査察対応および継続的改善活動を通じて、試験運営の質向上に貢献する
  Support audit readiness and continuous improvement initiatives to enhance trial execution

Essential Requirements

• 科学系またはヘルスサイエンス分野の学士号を有していること
  Bachelor’s degree in a scientific or health‑related discipline
• 臨床試験における実務経験を3年以上有し、モニタリングまたは試験管理に携わった経験があること
  At least three years of experience in clinical research, including trial oversight or monitoring
• 臨床医薬品開発プロセス全般への理解を有し、試験運営に関する知識を備えていること
  Solid understanding of the clinical drug development process and study execution
• グローバルかつマトリクス型の環境で協働できる能力
  Ability to work effectively in a global matrix environment
• 国際的な臨床試験基準および規制要件への理解
  Knowledge of international clinical trial standards and regulatory requirements
• 英語での円滑なコミュニケーション能力（読み書き・会話）
  Fluency in written and spoken English

Desirable Requirements

• 臨床試験におけるプロジェクトマネジメントまたはStudy Lead経験
  Experience in clinical trial project management or study leadership
• 多国間試験やグローバルチームとの協働経験
  Experience working with global or multinational study teams

Benefits and Rewards

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https://www.novartis.com/sites/novartis_com/files/novartis-life-handbook.pdf

Commitment to Diversity and Inclusion

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Accessibility and Accommodation

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Additional Information

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Skills Desired

Clinical Research, Clinical Study Reports, Clinical Trials, Collaboration, Data Analysis, Financial Analysis, Health Sciences