Senior Clinical PMS Manager

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募集要項

会社概要

外資系医薬品会社です。国際的なバイオ医薬企業との合併により、日本市場に革新的なバイオテクノロジーを導入しています。高度な専門性を持つ医薬情報提供活動を通じて、日本市場でのプレゼンスを高めています。がん、がん免疫および不妊治療領域を重点領域に、革新的なヘルスケア・ソリューションを日本の皆様に提供しています。

業務内容

• Accountable for day to day activities of all aspects of the operational management of local post-marketing studies (PMCT and PMS), including study timelines, resources, allocation and management of product (re-) supply, problem identification and resolution, status reports and budget to ensure timely delivery of completed study reports to the project teams
• Accountable for the oversight of investigator-initiated studies granted by the company, including the support of the set-up and operational assessment of investigator-sponsor, tracking performance and payments according approved plan, managing product supply, if applicable, coordinating internal review of final report
• Manage independent consultants including CROs, clinicians, independent CRAs, or statisticians when required by the project including selection, coordination of project specific training, and payment
• Develop and monitor study budget and timelines
• Monitor work to ensure quality
• Ensures that trial status is tracked and entered into the respective Clinical Trial Management System
• Contribute to the planning and set-up of a study and provide planning parameters
• Overseeing external providers, Act as an interface between Global Clinical Operations and local organizations (Global Operations)

応募条件

WORK EXPERIENCE:

• At least 5 years of experience in clinical research in a CRO, pharma or biotech company
• Experience of Post-marketing clinical trials or post-marketing studies or investigator-initiated studies.
• Experience in clinical trial planning and conduct
• Thorough knowledge of ICH GCP

JOB-SPECIFIC COMPETENCIES & SKILLS:

• Demonstrated good interpersonal skills
• Demonstrated good written and verbal communication skills
• Demonstrated good presentation skills
• Demonstrated ability to handle and oversee multiple tasks simultaneously and to prioritize in a meaningful way
• Analytical skills, quick perception and good judgement
• Fluency in English (oral and written) plus local language
• Experience in clinical trial planning and conduct
• Thorough knowledge of ICH GCP

給与

1200 - 1700 万円

勤務地

東京