Pfizer

[R&D] スタディマネジャー/Japan Study Manager

Posted Yesterday

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Tokyo

Hybrid

Mid level

Artificial Intelligence • Healthtech • Machine Learning • Natural Language Processing • Biotech • Pharmaceutical

We’re in relentless pursuit of breakthroughs that change patients’ lives.

The Role

The Japan Study Manager oversees clinical trials in Japan, ensuring patient safety, regulatory compliance, and quality execution while managing relationships with CROs and investigator sites.

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

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.
P rovides 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

Top Skills

GCP

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The Company

HQ: New York, NY

121,990 Employees

Year Founded: 1848

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.