Company
[R&D]スタディマネジャー/JapanStudyManager
Neural analysis suggests this role is
optimal for Mid+ candidates.
“[R&D] スタディマネジャー/Japan Study Manager. Manage and oversee studies in Japan. Ensure patient safety and quality”
What You'll Achieve.
Ensure patient safety and welfare; Ensure quality study execution; Ensure timely delivery of quality study data; Achieve recruitment targets; Maintain investigator and study coordinator engagement
Industry & Context.
Resolve protocol-related issues
What They're Looking For.
Must Have
4 years relevant experience, 2 years relevant experience, Excellent writing and communication skills in both Japanese and English
Nice to Have
Study management and site management experience, Working knowledge of GCPs, monitoring, clinical and regulatory operations
What You'll Do.
Manage and oversee studies in Japan
Ensure patient safety and quality
Ensure quality oversight of CRO
Manage investigator site relationships
Resolve protocol-related issues
Ensure timely communication
How You'll Work.
Team & Collaboration
Collaborate with CRO and sites; Act as core member of Study Team; Represent CRO on study execution matters; Communicate with global and local study team
Communication Scope
Excellent writing and communication skills in both Japanese and English
Process & Methodology
Manage study start-up, Manage enrollment, Manage database release, Manage study monitoring plans
Full Job Description
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. * 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
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