Job Description

Job Description

The Manager, Clinical Quality Management is responsible for managing local SOP, TMF plan, relevant systems/process for clinical operation, Quality oversight of clinical trial, supporting for planning and conducting global annual audit plans, and all activities to maximize clinical operation capability across studies for Japan.

He/She collaborates with multiple functions in Quantitative Sciences and Development Operations (QSDO) and R&D Quality & Compliance (RDQC) to be consistent with global process and also work within and outside R&D such as global/local finance or sourcing team.

He/She serves as the leader of the Japanese inspection response team responsible for preparing for and responding to inspection conducted by PMDA. Also he/she acts as the primary point of contact for the global inspection team and regulatory authorities, leading the coordination of inspection responses.

As part of vendor management responsibilities, he/she collaborates with stakeholders both within and outside the R&D department, such as Japan Study Lead (JSL), Clinical Financial Planner (CFP), Global/Local finance, and sourcing teams, to be responsible for budget management and contract management processes of local CROs and vendors.

業務内容：

Clinical Quality Managementは、Local SOP、TMF計画、臨床オペレーション業務に関連するシステム/手順、臨床試験の品質管理、グローバルによる年間監査計画の計画及び実施の支援等、日本での試験全体の臨床オペレーション業務遂行能力を最大化するための業務及び品質確保に関する責任を負う。

これらの業務を遂行するにあたり、Globalのプロセスと一貫性を保つため、Quantitative Sciences and Development Operations（QSDO）及びR&D Quality & Compliance（RDQC）等のグローバルの複数の部門と協力する。

PMDAによるGCP調査の準備及び対応にあたり日本の査察対応チームのリーダーとして、グローバルチーム及び規制当局との窓口となり査察対応をリードする。

Vendor management業務として、国内CRO及びその他のvendor管理を支援するためJapan Study Lead（JSL）、Clinical Financial Planner（CFP）、Global/Localの財務やソーシングチームなど、R&Dの内外のステークホルダーと協力し、主に予算管理及び契約管理のプロセスに責任を負う。

Qualifications

• Total 10+ year experience in clinical development field and 5+ year experience of managing clinical trial activities or GCP compliance.
• Need global study experience, Quality control including maintenance of CTMS, TMF or SOP.
• Thorough understanding of GCP regulations, guidelines, and industry trends.
• Business-level English to collaborate effectively with the global team.
• Science background and education (Bachelor’s Degree or equivalent)

必須要件：

• 臨床試験に関する業務での 10 年以上 の経験、臨床試験管理業務もしくはGCPコンプライアンス専門業務での 5 年以上 の経験。
• 国際共同試験の経験、CTMS、TMF、SOPを含む治験の品質管理業務の経験が必要。
• GCPの規制、ガイドライン及び動向を十分に理解している。
• グローバルチームとの協業にあたり、ビジネスレベルの英語力を有している。
• 自然科学系の大学卒以上の方（もしくは同等の経歴を有する方）。

Additional Information

Why Biogen?

We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.

At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired.  Read on to learn more about our DE&I efforts.

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