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The Study Management Associate III is part of a global study management team and plans, executes and manages one or more Phase 0-4 clinical trials. The role provides study-level oversight and leadership, supports study materials and systems management, and helps ensure quality execution in accordance with timelines and budget.

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応募資格

必須

Bachelor’s Degree or OUS equivalent required
Must have at least 4 years of progressive Pharma-related/clinical research-related experience with a high level of core and technical competencies
Competent in application of standard quality procedures (SOP, ICH/GCP, Global Regulations)
Experienced user of systems such as EDC, IRT, CTMS, and eTMF
Strong analytical and critical thinking skills to evaluate complex issues from multiple perspectives to actively develop strategies and drive smart decision making to support acceleration of study timelines and enable a well-run study
Excellent organizational and time management skills, strong attention to detail.
Exceptional interpersonal skills with ability to communicate effectively in a clear and persuasive manner in a global setting; proficient in business/technical English-language (oral and written)
Proactive, collaborative mindset
Ability to work independently in a fast-paced global team environment

歓迎

Preferred: Exposure to study initiation through completion activities; global study exposure

求める人物像

Strong analytical and critical thinking skills to evaluate complex issues from multiple perspectives to actively develop strategies and drive smart decision making to support acceleration of study timelines and enable a well-run study
Excellent organizational and time management skills, strong attention to detail.
Exceptional interpersonal skills with ability to communicate effectively in a clear and persuasive manner in a global setting; proficient in business/technical English-language (oral and written)
Proactive, collaborative mindset
Ability to work independently in a fast-paced global team environment

募集要項最終確認 11/4

職種: 臨床開発・薬事
雇用形態: Full-time
給与: 記載なし
勤務地: Minato City, Tokyo
働き方: This is a global role and may be located virtually.
経験年数: 4年以上
学歴: 大学卒業以上
掲載日: 2026/10/13 06:28（23日前）
最終確認: 2026/11/04 20:04（1日前）

仕事内容

Purpose

As a Study Management Associate III, you will be part of a dynamic, centralized study management team that is responsible for the execution of our global clinical trials and a key member of the study team. The Study Management Associate III works as an independent, contributing member of a cross-functional and global partnership to plan, execute and manage one or more Phase 0-4 clinical trials under the guidance of the Study Project Manager and SMA Manager. The Study Management Associate III works to ensure that assigned studies are executed with quality and efficiency, in accordance with timelines and budget to support broader company strategic objectives. The Study Management Associate III is expected to work in accordance with all AbbVie Ways of Working. This is a global role and may be located virtually.

Responsibilities

The Study Management Associate III is expected to work independently as a clinical study leader and contributor with appropriate support from the Study Project Manager on the following activities in compliance with quality standards (ICH/GCP, Global Regulations, and AbbVie policies and procedures):
Study-level oversight and leadership of one or more global trials in a cross-functional environment for activities from inception through closure, connecting functional work and strategic work across the global study, including but not limited to:
o Supports the Study Project Manager in strategic leadership of the cross-functional team through stakeholder engagement and influence to drive deliverables and timelines, including strategy development, meeting facilitation, and timely documentation at the study level to drive for timely execution of clinical trial(s)
o Vendor management, including Request for Proposal (RFP)/initiation, selection, Scope of Work development & review, deliverable oversight, and risk management for one or more external vendors, e.g., central lab, recruitment, imaging, internal and external committees
o Recruitment management, including thoughtful review of intelligence data, leadership, cross-functional development, and execution of recruitment strategies and mitigation planning on a global scale from country feasibility through subject recruitment and retention
o Leadership of assigned meetings (cross-functional (internal), vendor, and/or investigator) and provision of regular updates on study status, e.g., agenda development, minutes curation and filing
o Ensure inspection readiness and participate in related activities
Risk identification, mitigation, and management, including timely issue review, escalation, and management to support trend analysis and risk prevention.
Co-development and management (review, revision, tracking and filing) of study materials, including but not limited to:
o Protocols, regulatory submissions, patient reported outcome measures, study execution plan, informed consent, site budgets and agreements, clinical study report, training materials, newsletters, presentations for various stakeholders
o CTMS and eTMF management to ensure compliance/inspection readiness, support trend analyses and support timelines
o EDC, IRT, and ePRO, which includes review of design specifications, participation in user acceptance testing, and contribution to development and review of associated plans and key risk indicators, as well as system management activities like access support, query resolution, and oversight
o Management of investigational product and other associated study supplies
Provide engaging training to identified stakeholders as needed, e.g., study team members, vendors
Support global submission strategies
Support process improvement initiatives or serve as a subject matter expert and/or mentor

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