Japan Study Manager 求人

仕事内容

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。

業務内容

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

応募資格

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
Excellent writing and communication skills in both Japanese and English is required

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Japan Study Manager

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