[R&D] Japan Study Manager

Tokyo - Japan

Monthly Salary: Not Disclosed

Posted on: Yesterday

Vacancies: 1 Vacancy

Job Summary

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

Required Experience:

Manager

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 & RESPONSIBILITIESResponsible for in country study/site management and clinical/scientific oversight activities of assigned clinical trials to ensure patient safety and q...

職務内容

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

Required Experience:

Manager

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Pfizer

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