CLINICAL STUDY MANAGER

求める人材：

＊：必須要件、+：推奨要件

• 職歴・免許

＊5年以上のJ-GCP/ISO14155 、人を対象とする医学系研究に関する倫理指針、臨床研究法に関連した職務

＊3年以上の外部サプライヤー（CRO、SMO等）の管理経験

＊プロジェクトマネジメント経験

＋医療関連の経験（看護師、薬剤師、技師等）

＋医療に関する知識を要する又は臨床開発に準じた業務経験

＋PMDA GCP適合性調査の経験

＋CRA経験

＋デバイス、疾患の知識

• 知識

＊J-GCP/ISO14155

＊人を対象とする医学系研究に関する倫理指針、臨床研究法及びその他の関連通知に関する知識

＋統計解析

＋データマネジメント

• スキル

＊異なる意見を受容できる高いコミュニケーション能力

＊高い問題解決力や情報分析能力

＊ロジカルシンキング

＊コンプライアンス及びクォリティを念頭においたビジネス思考

＊英語：ビジネスレベル（TOEIC 800程度）

＊日本語：ネイティブレベル

• 学歴

＊学士号

＋博士又は修士（理系）

Job Title: Clinical Study ManageR

Department: Japan Clinical and Medical Affairs, OU Clinical         

Reporting to: OU Clinical Division Manager                             

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Background

The Clinical Research Department is responsible for the evaluation/assessment of the safety and efficacy of new medical devices through domestic and global clinical research/trial and the submission to MHLW (PMDA) for the manufacturing and marketing approval. For the devices that obtain manufacturing and marketing approval, investigation/research is conducted to collect, detect, and confirm information on the quality, efficacy and safety of the medical device when used in general practice, these are information regarding the appropriate use and safety of the product which could not be collected during a clinical trial. Also, by conducting studies such as Post Market Release studies, new evidence are collected to investigate further clinical application for Medtronic products.

Clinical research/trial in Medtronic is conducted by 3 departments, Clinical Research Department, Medtronic Core Clinical Solutions（MC2）and Corporate Clinical Quality Compliance(CCQC). MC2 is mainly in charge of Monitoring and Pharmacovigilance, and CCQC oversees audits.

CVG/DIB clinical members, who are part of the Clinical Research Department, will oversee Cardiovascular and Diabetes related medical devices, and will be at the center of a project, communicating and cooperating with domestic/foreign counterparts and departments.

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Job Summary

Clinical Study Manager (CSM) is responsible for managing and leading a clinical team to execute different types of clinical studies such as clinical trials and post market release studies, develop strategies for assigned clinical study considering business circumstances and regulatory requirements, and collaborate with not only internal team members including domestic/global study team, regulatory affairs department, but also external parties including suppliers, government agencies, medical staffs and physicians.

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Main responsibilities

1. In charge of the Clinical Study Manager (CSM) role as a primary contact of assigned clinical study

2. Develop a clinical study plan and create study execution documents.

3. Work closely with stakeholders including PMDA and/or investigators throughout all the phases of clinical study and negotiate study progress and study execution plans with them.

4. Management of ongoing/new clinical research/trial.
   • Selecting external suppliers
   • Clarifying milestone and managing the study progress
   • Create and execute agreements with investigational sites and/or external suppliers.
   • Contributing in data collection using EDC or paper CRFs and data management using internal systems
   • Creating and overseeing milestone and budget planning/management
   • Overseeing investigational device management

Secondary duties/responsibilities as applicable:

• • Contributes in creating Statistical Analysis Plan and conducting the analysis according to plan.
  • Participate in data publication planning, and publishing outcomes.

5. Overseeing PMDA reporting and responses.

6. Working with the internal audit team for internal audits

7. Work with external organization (such as PMDA office of conformity audit) for inspection,

Job Qualification:

＊：Must Haves、+：Nice to Have

• Job Experience / Qualification

＊At least 5 years of work experience related to J-GCP/ISO14155, Ethical Guidelines for Medical and Health Research Involving Human Subjects, and Clinical trial Acts.

＊At least 3 years of experience managing external suppliers.

＊Project Management

＋Experience in the medical field (Nurse, Pharmacist, Technicians and etc.)

＋Work experience with Clinical Research or work requiring medical knowledge

＋Experience with PMDA GCP conformity inspection

＋CRA experience

＋Knowledge of medical devices and diseases

• Knowledge

＊J-GCP/ISO14155

＊Ethical Guidelines for Medical and Health Research Involving Human Subjects, Clinical trial Acts and other related notifications

＋Statistical Analysis

＋Data Management

• Skills

＊Excellent communication skills embracing diversity

＊Strong problem-solving skills and analytical skills.

＊Logical thinking skills

＊Business minded with compliance and quality-oriented

＊English：Business Level（TOEIC score around 800）

＊Japanese：Native Level

• Education

＊Bachelor’s Degree

＋Doctorate or Master’s degree (Scientific field)