職務内容
スタディ・マネジャーは、日本国内において治験の管理・監督を担い、CROや治験実施医療機関と連携しながら、治験参加者の安全と福祉、治験の品質を確保し、治験の計画通りの実施をリードします。グローバル・ローカル双方と連携し、課題解決や進捗管理も担当します。
Job Summary & Responsibilities
- Responsible for in country study/site management and clinical/scientific oversight activities of assigned clinical trials to ensure patient safety and quality study execution in accordance with applicable prevailing laws, Good Clinical Practices (GCP), and Pfizer standards.
- Provides quality oversight to the CRO and of the CRO deliverables related to study execution. Leads and coordinates the execution of a clinical trial from study start-up through database release and inspection readiness to ensure timely delivery of quality study data. Provides leadership to the teams in the setting of realistic recruitment targets and delivery milestones as the single point of accountability for detailed study start-up and monitoring plans and for delivery to the agreed plans
- Act as core member of the Study Team and will represent the CRO on matters of study execution.
- Accountable for managing investigator site relationships to ensure effective delivery of clinical trials (e.g., study start up, enrollment, database release), to safeguard the quality of investigator sites (e.g., site health, patient safety) and to maintain investigator and study coordinator engagement and satisfaction.
- Acts as local expert for the assigned clinical trials and brings that expertise to support the investigator site, which includes the investigator, study coordinator, pharmacist etc, and to oversee and support the site monitor in the conduct of clinical trials. This role is responsible for the resolution of protocol-related issues at the local level.
- Ensure timely communication with bidirectionally between global and local study team.
Qualifications / Skills
Training and Education Preferred:
- Study management and site management experience
- Working knowledge of GCPs, monitoring, clinical and regulatory operations
- BS – minimum of 4 years relevant experience
- MS/PhD – minimum of 2 years relevant experience
Language:
- Excellent writing and communication skills in both Japanese and English is required.
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Medical
-
Tokyo Pfizer+This role involves managing clinical trials in Japan including study start-up through database release and inspection readiness to ensure timely delivery of quality study data. · +
-
ST-NGU 戦略コンサルタント職
1週間前
Tokyo KPMGジャパン/KPMG Japan ￥4,000,000 - ￥10,000,000 per yearKPMGコンサルティング(KC)は監査、税務、アドバイザリーの3つの分野でサービスを提供するプロフェッショナルファームです。KPMGグローバルでは現在、世界142ヵ国のメンバーファームに約275,000名のプロフェッショナルを擁し、サービスを提供しています。KPMGコンサルティングは、KPMGジャパンのアドバイザリーグループに属し、グローバル規模でのビジネストランスフォーメーション(事業戦略から事業モデルの変革やオペレーションの改善、ITテクノロジーを活用したビジネス改革など)やリスクマネジメントといったコンサルティングサービスを提供しています。 · ...
-
Tokyo, Japan CooperCompaniesThe Regulatory Affairs Senior Specialist shall be responsible for contributing and leading the Regulatory Affairs (RA) for the CooperVision Japan business. · ...
-
Tokyo CooperVisionThis individual is expected to be a strong assistant to the RA Manager and partner to Quality Assurance (QA) team in Regulatory Affairs for CooperVision Japan business. · ...
-
ST-MES 戦略コンサルタント職
2ヶ月前
Tokyo KPMGジャパン/KPMG JapanKPMGコンサルティング(KC)について · KPMGは監査、税務、アドバイザリーの3つの分野でサービスを提供するプロフェッショナルファームです。KPMGグローバルでは現在、世界142ヵ国のメンバーファームに約275,000名のプロフェッショナルを擁し、サービスを提供しています。KPMGコンサルティングは、KPMGジャパンのアドバイザリーグループに属し、グローバル規模でのビジネストランスフォーメーション(事業戦略から事業モデルの変革やオペレーションの改善、ITテクノロジーを活用したビジネス改革など)やリスクマネジメントといったコンサルティングサービスを提 ...
-
Tokyo, Tokyo Cybereason Remote jobSales Operation Specialist is a high impact role that will afford you the ability to shape our systems and processes for long term sustainability while working with a small agile team. · ...
-
Shibuya JLL Japan+ Manage project finances for capital projects within targeted percentage of budget.+ Identify cost savings on all projects. Meet firms' goals for cost avoidance / savings+ Submit timely cost and schedule change requests+ Provide the delivery and management of transition before o ...
-
Manager, Advisory
2ヶ月前
Shibuya JLL JapanThe position is responsible for providing superior client services on FM (Facility Management) and PM (Project Management) consultation.Provide administrative support within the Advisory team and Work Dynamics Account and collaborate with the Sales team to create sales materials ...
-
Shibuya-ku, Tokyo JLLThe position is responsible for providing superior client services on FM (Facility Management) and PM (Project Management) consultation, and the support for the account team under the transition stage or the lack of key resources. · ...
-
Manager, Advisory
1ヶ月前
Shibuya-ku, Tokyo JLLWe are seeking an experienced Manager to join our team at Work Dynamics Account Management. As Manager, you will play a key role in providing superior client services on FM (Facility Management) and PM (Project Management) consultation. · Suport transition activities moving smoot ...
-
東京都 千代田区, LenovoWe are Lenovo. We do what we say. We own what we do. We WOW our customers. · Consumer営業部門のTrusted Advisorとして成長戦略策定支援・事業運営支援・改善提案を行う。 左記実現のためのデータ分析資料作成、関連部門との協業、営業メンバーに対するコミュニケーション活動を含む。 · Consumer事業活動に関するBMSを設計・構築・運用する。レビューのファシリテーションおよびトラッキング。 左記業務遂行を目的とした週次・日次業績データ分析管析・資料作成を含む。 ...
-
Chiyoda IncyteThe Associate Director, Regulatory Affairs CMC will primarily be responsible for managing regulatory CMC submissions and strategy for Incyte development and marketed products.Ensures compliance to global regulatory guidance documents, regulations and laws as well as internal poli ...
-
〒- 東京都 千代田区 有楽町, Incyte Corporation+Job summary · Incyte Corporation is a fast growing biopharmaceutical company focused on the discovery, · development and commercialization of innovative therapeutics, · primarily for oncology.+Responsibilities · The Associate Director will primarily be responsible for managing r ...
-
Tokyo Cybereason Full timeCybereason's mission is to protect it all – delivering unparalleled prevention, detection, investigation, and response for all endpoints: workstations laptops mobile devices more · ...
