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2024.5.24 [Fri.]

Akihabara UDX 2F AKIBA_SQUARE

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Updated 2024-04-02
Activated 2024-04-02

Global Site Management Lead

Recruiter
Manager Level

This posting is managed by:	Michael Page International Japan K.K./マイケル・ペイジ・インターナショナル・ジャパン株式会社
Company Name	Company is not publicly visible
Job Type	Medical/Pharmaceutical/Bio/Fabric/Food - Clinical R & D
Industry	Medical/Healthcare Services
Location	Asia Japan Tokyo
Job Description	* Lead activities in global clinical trials, ensuring the successful planning, execution, and oversight of site monitoring activities. * Provide mentorship to less experienced staff, and foster a learning culture within the Clinical Development & Operations team, promoting continuous learning and innovation. Description * Develop and plan trial quality and risk monitoring/mitigation strategies as part of the Trial Team. * Author monitoring risk assessments and plans, ensuring sponsor oversight, trend analysis, and signal detection. * Develop operational Site Monitoring & Oversight plans, incorporating patient and site-centric design. * Offer expertise on Site Management and Monitoring, including appropriate training for Clinical Trial Managers (CT Managers) and Clinical Research Associates (CRAs). * Oversee Site Management and Monitoring activities conducted by CRO partners during clinical trial conduct. * Pre-identify important protocol deviations and site issues, continuously review and communicate risks on a trial level. * Execute Site and Monitoring Oversight, including visits, and implement follow-up actions and escalation as required. * Maintain a Risk-based Site Monitoring approach, updating Site Monitoring plans and trial-level documents in a timely manner. * Ensure timely cleaning and delivery of clinical trial data in coordination with the Trial Team and countries. * Support the compilation and review of the quality section for the clinical trial report, summarizing site monitoring activities. * Offer oversight of site monitoring activities for Japan, ensuring outsourced monitoring services meet quality standards. * Ensure study site monitoring activities according to GCP, BI-SOP/WI, protocol, and monitoring manual. * Coordinate inspection readiness activities on the study site level. * Perform site selection and site monitoring activities per BI SOPs, international and Japanese regulations/guidelines. * Escalate non-compliance and implement CAPA, manage site-related study KPIs, and ensure compliance with Monitoring visit report. * Adhere to international, local, and internal requirements in planning, conducting, and reporting clinical trials. * Support the development of company relationships with opinion leaders and establish good working relationships with investigational site staff, internal staff, and vendors. * Participate in working groups related to site monitoring and contribute to initiatives within CD&O Japan. * Create an environment that inspires and empowers colleagues, contributing to the acceleration of clinical development timelines. * Act as a Subject Matter Expert (SME) globally, mentor developing Site Monitoring Leads, and participate in global functional teams. * Demonstrate proactive and problem-solving behavior, clear and effective communication, and efficient teamwork aligned with organizational goals. Profile * University or comparable degree in life sciences or a related field. * Several years of equivalent professional education may be acceptable, supplemented by substantial knowledge and experience in Site Monitoring and Site Management processes. * Demonstrates a proven track record with multiple years of site monitoring and management experience across all stages of clinical trials. * Extensive experience in various therapeutic areas, covering site selection, initiation, conduct, and close-out phases of clinical development. * In-depth understanding of International Conference on Harmonization (ICH) regulations and Good Clinical Practice (GCP). * Familiarity with major regulations, including those of the US FDA, EMA, and PMDA. * Possesses cross-geographical experience and has worked effectively in a multi-cultural environment. * Native level Japanese * Business level English Job Offer * Contribute to expansion of a promising global bio-pharmaceutical company in Japan * Opportunity to work on APAC level projects * Opportunity to move from CRO into a pharmaceutical company Page Group Japan is acting as an Employment Agency in relation to this vacancy.
Company Info	* Leading global pharmaceutical company with expanding portfolio within the speciality care medicine field * Renowned for its commitment to patient well-being and advancement in medical science, our client is dedicated to bringing transformative therapies and medicines to improve and save lives worldwide.
Working Hours	Monday - Friday (09:00 - 17:00)
English Level	Fluent (TOEIC 865-)
Japanese Level	Fluent(JLPT Level 1 or N1)
Salary	JPY - Japanese Yen JPY 11000K - JPY 13000K
Other Salary Description	13,000,000

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