Bristol Myers Squibb Site Manager in SHINJUKU, Japan

• Responsible for managing the submission of initial and ongoing documents to the relevant IRB/MOH or other regulatory bodies for approval or acknowledgment Hub/country dependent• Coordinates Hub cross functional teams and acts as the main point of contact for a Hub with the global study team. Escalates operational issues to the Global Team and Hub Management• Coordinates Investigator meetings, internal training requirements and coordination of ongoing training of Investigators & site personnel and the local study teams Hub/country dependent• Ensures appropriate documents are maintained in electronic Trial Master File (eTMF). Responsible for the appropriate collection and filing of all documents required for Clinical Trial Package (CTP) which includes appropriate regulatory documents for site activation and ongoing study management.• Performs periodic review of the eTMF to ensure site level documents are appropriately filed.• Reviews Site Monitoring visit reports, takes action within the timelines specified and escalates issues and ensures appropriate documentation of issues.• Documents Site level issues in clinSIGHT and ensures issues are escalated to the appropriate level and resolved in the appropriate timeframe• Performs Clinical Listing Review for the role of Site Level Reviewer according to timeframes in the Data Review Plan Hub/country dependent• Ensures database locks are met at a site and appropriate site management support for central teams during Database Locks Hub/country dependent• Ensure Clinical Trial Managements Systems (CTMS) eg. Eclipse are maintained for all country and site level milestones and drivers. Ensure Country replans in Eclipse are performed in alignment with protocol expectations.• Ensures protocol/amendment approvals dates are capture appropriately in the CTMS eg. Eclipse• Manages site level access to vendor systems eg. eDC, IVRS, Laboratory and Imaging Portals• Ensure study specific supplies are available at Investigational sites• Ensures CTMS is maintained for Investigational Product supply delivery to sites• Ensure Hub level staff have appropriate access to study related systems eg. eDC, IVRS, Laboratory Portals• Ensuring Post Drug Access is available for patients where appropriate (Hub/country dependent)• Executes Country profiling inclusive of site feasibility for new studies being considered for participation within the Hub. Includes engagement with local Key Opinion Leaders (KOL), local Medical organization, feedback from Investigators and Clinical Trial staff. Feeds back information collected in the country profiling process to the central team.• Manages all steps in clinical trial execution from country profiling, hub commitment, site feasibility and site selection, target setting, study start-up, site activation, study recruitment & maintenance, database lock to final study closure. • Ensure studies conducted in the Hub and the local study team are Inspection ready. Acts as the main contact in the Hub for any audits conducted. Ensures the local team prepares the CAPA for Hub audit level findings. Drives CAPA review and implementation.• Leads problem solving and resolution efforts including management of risk, contingencies, issue resolution and escalation to the appropriate stakeholder/s.Disclaimer: The responsibilities listed above are only a summary and other responsibilities will be requirements as assigned)

ü プロジェクトの目的を達成するために、社内のステークホルダーと密に連携し、試験の進捗を管理する。ü 治験を適切に実施できる医療機関/治験責任医師の情報を収集、選定する。ü Clinical Trial Management Systemを用いて、治験情報を管理する。ü シニアサイトマネジャーおよびサイトモニターと協働し、タイムラインに沿った症例登録の戦略を構築、進捗を管理する。ü スタディチームメンバーと治験実施医療機関における情報を共有し、担当医療機関における問題を事前に特定、解決案を提案、実行する。ü スタディチームメンバーと協働し、治験開始に必要なドキュメント、資料を作成する。ü 治験実施医療機関からの問い合わせ、質問に対して自主的に回答し、解決を図る。ü サイトモニターと協働し、治験実施医療機関またはCountryレベルの潜在的なリスクを特定し、解決策を提案する。ü 試験関連文書、必須文書が適切に管理、保管されていることを定期的にレビュー、確認する。ü GCP、ガイドライン、社内/治験実施医療機関のSOPに従った治験依頼、手続き書類作成、治験費用および契約の交渉、契約締結において、サイトモニターをサポートする。ü SMP、SOP、GCP、ガイドラインおよび規制要件に従い、被験者の安全性を確保する。ü モニタリングを含む臨床開発業務の効率化/標準化を図ることで業務を簡素化するとともに、求められる質を維持するためのツール作成やトレーニングの実施等の方策を講じる。ü 予算およびリソースの有効活用を最大化し、目標達成に向けて革新的なアイディアを提案し、目標達成に導く。ü スタディチームメンバーをメンタリングする。ü 組織内で求められるワークキンググループ、タスクフォース、SME(Subject Matter Expert)に貢献する。必要に応じ、規制当局による調査に対応する。ü CROおよび社内ステークホルダーと協働し、Outsource試験を管理する(実施する場合)。ü ラインマネジャーより任命されたその他業務を遂行する。

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