[R&D] スタディマネジャー/Japan Study Manager job opportunity at Pfizer.

Home Jobs In Japan Tag: Job [R&D] スタディマネジャー/Japan Study Manager position at Pfizer


DatePosted 26 Days Ago bot
Pfizer [R&D] スタディマネジャー/Japan Study Manager
Experience: 4-years
Pattern: full-time
Country:
apply Apply Now
Salary:
Status:

Job

Copy Link Report
degreeOND
loacation Japan - Tokyo, Japan
loacation Japan - Tokyo....Japan

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

Other Ai Matches

辉瑞-医学信息沟通地区经理-代谢事业部-武汉 Applicants are expected to have a solid experience in handling Job related tasks
IC-I&I-ZHEJIANGHANGZHOU/炎症与免疫产品线浙江杭州 Applicants are expected to have a solid experience in handling Job related tasks
Hemo Marketing Portfolio Lead Applicants are expected to have a solid experience in handling Job related tasks
Focal Recruiter 候选人体验招聘主管 Applicants are expected to have a solid experience in handling Job related tasks
Digital – Manager, Data and Analytics Engineer Applicants are expected to have a solid experience in handling Data and Analytics Engineer related tasks
remote-jobserver Remote
Neuroscience Health and Science Professional (HSP) - Warwick, RI Applicants are expected to have a solid experience in handling RI related tasks
辉瑞生物制药-医学信息沟通专员-GE-宿州灵璧 Applicants are expected to have a solid experience in handling Job related tasks
代谢事业部-医学信息沟通专员-广州 Applicants are expected to have a solid experience in handling Job related tasks
Operations Engineer Applicants are expected to have a solid experience in handling Job related tasks
SMO- Penicillin Sterile Manufacturing Operator(2nd shift-3:00p.m-11:30p.m) Applicants are expected to have a solid experience in handling Job related tasks
商务项目与创新经理Channel Project & Innovation Manager Applicants are expected to have a solid experience in handling Job related tasks
MIC RM-Metabolism BU-Chengdu/Chongqing Applicants are expected to have a solid experience in handling Job related tasks
Kotlovođa (m/ž) Applicants are expected to have a solid experience in handling Job related tasks
Principal Scientist-Process Development Applicants are expected to have a solid experience in handling Job related tasks
Director, MED Product Group Lead – Medical Evidence Generation Applicants are expected to have a solid experience in handling MED Product Group Lead – Medical Evidence Generation related tasks
辉瑞-医学信息沟通专员-抗感染-赣州 Applicants are expected to have a solid experience in handling Job related tasks
创新可及性方案负责人-北京 Applicants are expected to have a solid experience in handling Job related tasks
Sr Manager, Experience Design (Agentic & Conversational Product Design) Applicants are expected to have a solid experience in handling Experience Design (Agentic & Conversational Product Design) related tasks
Area Rare Cardiac Specialist (ARC), Rare Cardiac - Oklahoma City, OK Applicants are expected to have a solid experience in handling Rare Cardiac - Oklahoma City, OK related tasks
市场部负责人-炎症免疫 Applicants are expected to have a solid experience in handling Job related tasks
Health Representative/Senior Health Representative/Account Executive, Hematology & Rare Disease Applicants are expected to have a solid experience in handling Hematology & Rare Disease related tasks
Infrastructure Hosting&Storage Operations Engineer Applicants are expected to have a solid experience in handling Job related tasks
[R&D] Statistician, バイオメトリクス・データマネジメント統括部　統計担当者 Applicants are expected to have a solid experience in handling バイオメトリクス・データマネジメント統括部　統計担当者 related tasks