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The Role
Lead and manage clinical trial execution in Japan, overseeing CROs and investigator sites to ensure patient safety, GCP compliance, timely enrollment, data quality, and inspection readiness while coordinating with global and local teams.
Summary Generated by Built In
Japan Study Manager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
QUALIFICATIONS / SKILLS
Training and Education Preferred:
Language:
Work Location Assignment: Hybrid
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 .
Medical
#BI-Hybrid
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.
Work Location Assignment: Hybrid
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 .
Medical
#BI-Hybrid
Skills Required
- 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
What the Team is Saying
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Pfizer Compensation & Benefits Highlights
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Healthcare Strength — Official materials describe comprehensive medical, dental, vision, and mental-health support, plus fertility/family‑building and transgender‑inclusive coverage; eligible Pfizer medications are noted as available at no cost in U.S. plans. Wellness resources such as telehealth and preventative programs are also emphasized.
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Retirement Support — Company documents highlight a 401(k) with matching contributions plus an additional Retirement Savings Contribution beyond the match. Financial planning support and company‑paid life and disability insurance further bolster long‑term security.
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Leave & Time Off Breadth — Corporate pages and job postings describe paid vacation and holidays, caregiver leave, and paid parental leave for both parents. Materials also note that details can vary by role and location.
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The Company
What We Do
Our purpose ensures that patients remain at the center of all we do. We live our purpose by sourcing the best science in the world; partnering with others in the healthcare system to improve access to our medicines; using digital technologies to enhance our drug discovery and development, as well as patient outcomes; and leading the conversation to advocate for pro-innovation/pro-patient policies.
Why Work With Us
We are the inventors, the problem solvers, the big thinkers — those who surmount any hurdle to deliver breakthrough medicines to the people who are counting on them the most.
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Pfizer Offices
Hybrid Workspace
Employees engage in a combination of remote and on-site work.
Typical time on-site:
2.5 days a week
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