Study Management Associate III /Clinical Trial Manager

• ※The expected offer grade is 15 or 16
• (Depending on the candidate's experience as well as interview evaluation) 

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

• exposure
• アッヴィは、機会均等を重視する雇用主であり、誠実な企業活動、革新の推進、人々の生活への貢献、そして地域社会への貢献に努めています。雇用機会均等に向けて、障がいを持つ方々も積極的に支援しています。