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About the Role

The Japan Study Manager will oversee and manage clinical trials within Japan, collaborating with CROs and clinical sites to ensure participant safety, data quality, and adherence to trial protocols. This role involves coordinating with global and local teams to resolve issues and manage progress.

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.
• Acts 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.

Requirements

• 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.

Skills

• Study management
• Site management
• GCPs
• Monitoring
• Clinical operations
• Regulatory operations
• Japanese language
• English language

Location

• Japan

Work Type

• Hybrid

Experience Level

• 4 years relevant experience (BS)
• 2 years relevant experience (MS/PhD)

Education Level

• BS
• MS/PhD

About the Company

• Pfizer careers are like no other. In our culture of individual ownership, we believe in our ability to improve future healthcare, and potential to transform millions of lives.
• We’re looking for new talent to join our global community, to unearth new innovative therapies that make the world a healthier place.

Equal Opportunity

• Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
• To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers.