配属組織：開発本部 クリニカルオペレーションユニット
募集背景：今後更にグローバル開発を強化するため
【職務内容】
試験の責任者（治験実施責任者）として日本試験をマネジメントしていただきます。
同社のCTMは直接グローバルメンバーとも対等な立場でやりとりをしていただきます。大きい裁量権があるため、自分がリードしているという実感・自分の力を発揮しやすい環境であります。開発だけでなく、研究や生産・営業など他部門とのコミュニケーション機会も多く、医薬品開発を幅広く理解・関わることが可能です。
【具体的には…】
■Description
Duties and Responsibilities
Reporting to the Associate Director of Clinical Operations, the Clinical Operations Manager will be accountable for managing and / or supporting the clinical operation activities for clinical studies. This person will be key in driving the clinical studies day to day activities, ensuring on time delivery of main clinical milestones, as well as respect of GCP.
■Duties and Responsibilities
- Lead, manage and / or support and co-ordinate the conduct of assigned clinical trials from study start-up to close out in accordance with GCP
- Oversees the quality of the clinical operations for the studies he/she is in charge of？
- Ensure that study is Inspection ready through the study lifecycle and partake in CAPAs when needed
- Collaborates with cross functional stakeholders to ensure timely and on budget execution of clinical trial deliverables
- Collaborates with Clinical Science, data management and statisticians ensuring data base maintenance, interim and final database locks.
- Manages clinical sites and academics institutions, ensures adherence for keeping clinical records, source documents, data entry, manages clinical trial logistics, applications (IRB, local agencies), lab supplies, lab tracking of samples.
- Planning, management and reporting of clinical studies through oversight of cross-functional study activities, identification and resolution of issues, and communication of study timelines/deliverables
700万円～1100万円※経験に応ず
CRA(臨床開発モニター)
ハイクラス転職エージェント「パソナキャリア」
