APAC Clinical Operations Lead | マイケル・ペイジ・インターナショナル・ジャパン株式会社/Michael Page International Japan K.K.の求人詳細

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2024.5.24 [Fri.]

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更新日 2024-04-02
掲載開始日 2024-04-02

APAC Clinical Operations Lead

人材紹介
マネージャーレベル

この求人の取扱い会社	マイケル・ペイジ・インターナショナル・ジャパン株式会社/Michael Page International Japan K.K.
企業名	会社名非公開
職種	メディカル/医薬/バイオ/素材/食品 - 臨床開発系
業種	製薬メーカー
勤務地	アジア日本東京都
仕事内容	* Drive impactful change in rare disease medicine, overseeing study management, site relationships, and strategic planning in a supportive and inclusive remote work environment. Description * Effectively oversee the management of multiple trials in designated regions. * Lead the fulfillment of study requirements, timelines, and compliance within specific areas, aligning with global strategies. * Facilitate strategic communication between various stakeholders involved in studies across different regions. * Serve as an expert in policies, regulations, and related inspection processes. * Foster and maintain relationships with various stakeholders, including investigator sites. * Manage and execute study activities at the regional level, ensuring completion. * Collaborate with partners to address study challenges and milestones proactively. * Offer regional insights for the development of study documents and training materials. * Identify potential study sites, conduct assessments, and provide recommendations. * Support site initiation, close-out visits, and monitoring activities. * Supervise the implementation of Monitoring Oversight Plans and assess quality metrics. * Ensure the readiness and compliance of Trial Master Files, addressing risks and issues. * Interact with peers to standardize study practices and enhance operational efficiency. * Contribute to special projects and participate in the development of SOPs and guidelines. * Provide guidance and mentorship to staff involved in Clinical Operations. * Potentially lead a team within a collaborative environment, focusing on performance and development planning. Profile * University degree, preferably in medical or biological sciences or discipline associated with clinical research. Advanced degree is preferred * Experience in pharmaceutical industry or relative academic experience * Extensive knowledge of clinical operations, project management tools and processes * Good experience of clinical development / drug development process in various phases of development and therapy areas. * Knowledge of process improvement methodology * Evidence of developing partnering skills * Native level Japanese * Business level English Job Offer * Lead and manage clinical operations for APAC R&D * Contribute to expanding portfolio in ultra rare diseases Page Group Japan is acting as an Employment Agency in relation to this vacancy.
企業について（社風など）	* US-based biotech specializing in research and devlopment of innovative treatments for rare genetic diseases where there are unmet medical needs.
勤務時間	Monday - Friday (09:00 - 17:00)
英語能力	ビジネス会話 (TOEIC 735-860)
日本語能力	ネイティヴレベル
年収	日本・円 800万円〜 1500万円