求人

Senior Clinical Study Manager

検索に戻る 今すぐ応募
公開日:   2021/02/26

職種

製薬

必須言語

英語: 上級ビジネスレベル

勤務地

東京

求人情報

【Role and Responsibility】

・  Oversee the delivery to plan of studies performed by external partners (CROs, vendors and Site) and

monitoring progress by identifying risk and solve operational issues.

・  Lead and manage all activities related to site management and monitoring with agreed timelines, budget and company standard quality.

・  Plan and deliver site selection/ patient recruitment strategy

・  Ensure the quality of clinical study data by raising queries and deviation and resolve issues in a timely

manner.

・  Develop and manage risk mitigation plans and contingency plans to execute CRO/site management

・  Lead activities associated with external/internal audits in corporation with Global QA and contribute to regulatory inspection in the area of assigned projects

・  Ensure that all study documents are ready for final archiving and ensure completion of Trial Master File.

・  Ensure translation into Japanese study document such as protocol, ICF

・  Escalate issues related to study management and contribution to resolve

・  Coordinate with global clinical team and manage progress and quality of the clinical studies.

・  Communication and negotiation with business partners (CRO, Contract Lab, etc.) and coordination with internal cross functional team and KOLs.

応募資格

【Qualification】 Mandatory ・  University degree (or equivalent), preferably in medical or biological sciences or discipline associate with clinical research. Advance degree is preferred ・  At least 6 years experiences from within the pharmaceutical industry or similar organization ・  Good experience of clinical development/drug development process in various phases of development and therapy areas ・  Extensive knowledge of clinical operations, project management tools and processes Nice to have ・  CNS (stroke etc) area experience ・  Global management and negotiation skill preferable 【Skillset】 mandatory ・  Developing and harmonizing team members ・  Influencing and partnership management ・  Business English TOEIC over 700 reading, listening, writhing skill ・  Native level Japanese