お仕事情報

お仕事情報

Clinical Trial Manager:SS-3477MY

  • 外資系企業
  • 女性が活躍
  • 管理職・マネジャー
  • 英語を活かす

2型糖尿病に特化した代謝性疾患の治療薬を開発しているバイオ製薬会社

求人コード SS-3477MY
募集職種 Clinical Trial Manager
職務内容 Reporting to the Asia Clinical Operations Director, you will support the Director, Clinical Operation Asia in overseeing local CROs for a phase Ⅲprogram in Japan and, ensures that operational study deliverables are implemented and executed according to timelines, budget, operational procedures, quality standards and are in compliance with clinical study protocols,SOPs, Japanese regulations and ICH/GCP guidelines.

1, Supervision of the study monitoring
・Supervise the outsourced study monitoring activities, including review of feasibility, intiation, monitoring, and close-out visits report, as well as the review of the Monitoring Plan and associated documents:
・Perform co-monitoring visits with the CRO's CRAs to evaluate site(s) and CRA's activities with respect to Japanese GCP, applicable regulatory standards, study protocol and procedures, as well as ensure CRA's and vendors' training:
・Contribute to design and implementation of study management plans (e.g. monitoring, vendor and TMF oversight...)
・Create, maintain and consuct regular quality review of the Japanese paper based file to ensure files are properly maintained and up-to-date, archived and stored;
・Ensure that supportive study supplies and documents are available (e.g. contracts, IWRS, lab kits, non-clinical supply materials);
・Participate to site identification and selection and review clinical trial notification(CTN) for PMDA before submission;

2, Participation to the study operational activities
・Contributes to the development and finalization of cross-functional deliverables (clinical study protocols, CRFs, informed Consent Forms, Study Reference Manuals, Clinical Study Reports and other study related documents);
・Support our Clinical Operation team for vendor activities and oversee adherence to scope of work and service agreements;
・Support the develoopment, management and tracking of study budget;
・Follows through with various CRO departments and performs audits on our behalf;
・Contribute to internal audits and PMDA inspections and monitor implementattion of corrective actions following audits and inspections;
・Support the handling/answering questions related to trial procedures and patients' eligibility;
・Assist Data Manager for coordination of data management activities;
・Ensure compliance with clinical study protocols, ICH-GCP, us and CRO's SOPs, regulatory requirement, high quality deliverable and respect of timelines at each step of the clinical study.
応募要件 You have a BS/BA in Life Sciences (e.g. Pharmacy, Biology or similar course).
You have 3 to 5 years experience in the pharmaceutical industry and solid knowledge of clinical drug development in an international environment.
Previous experience in diabetes or cardio-metabolic studies would be a plus.
You also have experoence with Clinical Study Management activities and with management of CROs and Vendors.
An exellent knowledge of PMDA, Japan and ICH/GCP regulations and guidelines is mandatory.
, proactive and your ability to work in a less structured environment will be a real asset to succeed in this position.
Your proactivity, your self-motivation combined with your strong collaborative skills and your interest in clinical operations will be a real asset to succeed in this position.
Professional English fluency is mandatory.
勤務地 東京
年収 900万円~1200万円
最終学歴 理系大卒
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