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[Innovative Medicine] Analyst II, Analytical Monitoring, Data Management and Central Monitoring, Integrated Data Analytics ＆ Reporting （IDAR）, IM R＆D

年収：応相談

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部署・役職名	[Innovative Medicine] Analyst II, Analytical Monitoring, Data Management and Central Monitoring, Integrated Data Analytics ＆ Reporting （IDAR）, IM R＆D
職種	CRA（臨床開発モニター）統計解析・SASプログラマー
業種	医薬品メーカー
勤務地	東京都
仕事内容	Johnson & Johnsonでは、健康がすべてであると信じている。医療イノベーションにおける当社の強みは、複雑な病気が予防、治療、治癒され、治療がより賢く、侵襲性が低く、解決策が個人的なものになる世界を構築することを可能にする。革新的医療とMedTechの専門知識を通じて、私たちは今日のヘルスケアソリューションの全範囲にわたって革新を起こし、明日のブレイクスルーを提供し、人類の健康に大きな影響を与えるユニークな立場にある。 ■About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Integrated Data Analytics and Reporting (IDAR) Analyst II Analytical Monitor ■Position Summary: The Analyst II Analytical Monitor is an individual contributor with knowledge of site monitoring and Analytical Risk Based Monitoring (ARBM) practices, data analytics, methods, processes, and technologies. Empowered by technology, optimized processes and targeted data analytics, Analytical Monitors will enable Site Managers to dedicate a greater proportion of their time for meaningful engagement with sites, driving improved performance, data reliability and site satisfaction. The Analyst II Analytical Monitor supports execution of processes and activities for multiple clinical trials in conformance to all relevant laws, regulations, guidelines, policies, and procedures. This position receives ongoing direction from their functional manager and/or other experts to achieve objectives. This position collaborates closely with Site Managers, other Data Management & Central Monitoring roles, & other internal partner functions and/or external service providers to achieve successful, cooperative partnerships. ■Principal Responsibilities: Conducts activities in compliance with J&J functional SOPs, processes and policies. May support innovation or process improvement projects which may include but are not limited to requirements development, user acceptance testing and identification of improvements to existing and new analytical tools. Facilitates smooth and effective communication, managing multiple communication streams. Follows agreed escalation pathways where needed. ■Analytical Monitor Role-Specific Responsibilities: Performs analytical monitoring activities for clinical trials within assigned scope of responsibility in line with portfolio timelines and priorities, including support of execution and close-out as outlined in the end-to-end process. This may also include support in local language to enable effective collaboration & execution. Analytical Monitors will conduct regular (fit for purpose) reviews at site and subject level that will help early detection of issues, and prevent recurrence Collaborates closely with the Site Manager and Central Monitoring Manager to action trends and signals detected at the site and subject level. Accesses various systems, databases and reporting tools to identify potential risks related to the site and subject level data quality, study participant safety and compliance by identifying trends and early warning signals Provides timely analytical data insights to support the Site Managers in making decisions on site prioritization and critical engagement. ■Principal Relationships: Functional contacts in J&J Innovative Medicine include but are not limited to Site Managers and Local Trial Managers. Functional contacts within IDAR include but are not limited to Functional Leadership, Central Monitoring, Data Management, Data Acquisition Experts, Clinical Programmers. External contacts include but are not limited to External Service Providers.
応募資格	【必須（MUST）】 Bachelor's degree (e.g., BS, BA) or equivalent professional experience is required, preferably in Health Sciences or Data Sciences. Advanced degrees preferred (e.g., Masters, PhD). Approximately 4+ years experience in Pharmaceutical, CRO or Biotech industry or related field or industry. Knowledge of trial site operations and study execution Working knowledge of regulatory guidelines (e.g., ICH-GCP). Demonstrated understanding of data analysis and familiarity with basic statistical concepts. Project, Issue, and risk management experience with ability to apply critical thinking & problem-solving skills, to drive solutions & helping to lead teams to successful outcomes. Experience working with technology platforms and systems used for the collection, analysis and reporting of data. Ability to effectively collaborate in an environment of cross-functional stakeholders, plan and coordinate tasks effectively. Strong ability to communicate effectively (written and verbal). Good written and verbal communications skills (in English). Knowledge of clinical drug development processes. 【歓迎（WANT）】 Working with complex data structures and reporting specifications Working with external data e.g., Safety Lab, PK, Simple Biomarkers, ECG, or similar. Possess proficiency in statistical analysis, data modelling, and data visualization techniques, or demonstrate strong knowledge in these areas. Knowledge of Risk-based Quality Management (RBQM)/Risk-Based Monitoring (RBM) / Quality by Design (QbD) concepts
受動喫煙対策	屋内禁煙
更新日	2025/09/17
求人番号	5730044

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