Associate, Study Management III

2週間前

Minato, Tokyo AbbVie

企業概要

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

求人内容

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:
  • 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)
  • 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
  • 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
  • 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
  • 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:
  • 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
  • CTMS and eTMF management to ensure compliance/inspection readiness, support trend analyses and support timelines
  • 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
  • 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

資格

Qualifications

  • 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

その他の情報

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。

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