Study Management Associate III /Clinical Trial Manager
AbbVie · Minato City
企業概要
About AbbVie
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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.
求人内容
- ※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
資格
- 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。