Summary
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.
About the Role
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
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
Benefits and Rewards: Learn about all the ways we’ll help you thrive personally and professionally.
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Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
Accessibility and accommodation
Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
