Specialist II / Senior Specialist, Clinical Data Strategy and Operations Group, Japan Data and Statistical Sciences

給与

記載なし

勤務地

東京都

休日

記載なし

雇用形態

正社員

どんな仕事かAIによる生成

The position supports mainly Japan/China clinical development projects in data management. It leads data management activities from study start-up through database lock, supports data quality and integrity, and contributes to regulatory submissions, inspection readiness and process improvement.

応募資格・募集要項・仕事内容を見る

応募資格

必須

At least 5 years of experience in pharmaceutical R&D including at least 3 years’ experience in data management and/or statistical sciences and programming areas. For Senior Specialist, 6+ years of experience in data management is preferred, having knowledge in CDISC(SDTM) and ICH E6(R3).
A bachelor’s degree in or equivalent knowledge of statistics/mathematics, pharmacy, biology, pharmacology or related scientific field focused on quantitative skills. A master’s or doctor’s degree is more favorable.
Proficient in English communication skills (TOEIC 750 or more or equivalent), with the ability to lead discussions with Global CDSO and regional study teams across time zones. Chinese communication skills are preferable.
Good leadership skills as defined by AbbVie core leadership behaviors.

募集要項最終確認 11/13

職種: 臨床開発・薬事
雇用形態: Full-time
役職: Senior Specialist
給与: 記載なし
勤務地: Minato City, Tokyo
働き方: 記載なし
経験年数: 5年以上
学歴: 大学卒業以上
掲載日: 2026/11/09 22:09（5日前）
最終確認: 2026/11/13 18:42（1日前）

仕事内容

求人内容

The position is responsible for providing support to mainly Japan/China clinical development projects in the area of data management. The support is supplied in the context of a cooperative, one team mindset, project-oriented effort and included data capabilities in general planning and execution of clinical trials, data management activities of individual trials, and regulatory submissions and inspections.
Serves as the subject matter expert and main point of contact for data management on assigned studies, primarily in Japan, China and other Asian countries/regions. Owns data-related start-up deliverables (e.g., eCRF, eCOA and IRT) from protocol development through system go-live, as well as strategies for data collection, data cleaning and database lock.
Leads data management activities end-to-end, from study start-up through database lock, and is accountable for data management timelines. Works with the global data management function and the study team, and uses operational analytics and project management tools to track progress and to escalate and resolve issues affecting timelines or quality.
Ensures that critical-to-quality (CtQ) factors and data criticality assessments are reflected in data collection design and downstream data systems.
Performs risk-based, continuous data review using dashboards and quality metrics, triages data quality issues, and drives site-level actions through effective cross-functional communication to keep data current and reliable.
Defines and manages study data flow from raw EDC data through mapped SDTM data, partnering with internal technology teams, service providers and vendors to support end-to-end data integrity.
Ensures adherence to applicable regulations, GCP, ICH guidelines, AbbVie SOPs and functional quality standards, and stays up to date on evolving guidance.
Supports regulatory submissions and maintains inspection readiness for assigned studies, including responses to health authority inspections (e.g., PMDA).
Influences without direct authority in cross-functional study planning, translates complex data and technology concepts into clear guidance for study teams, and leads or contributes to process improvement initiatives. Senior Specialists are also expected to coach and mentor team members.

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