Study Management Associate III /Clinical Trial Manager正規雇用Workday Global Grade: 16会社概要About AbbVieAbbVie'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 atwww.abbvie.com. Follow @abbvie onLinkedIn,Facebook,Instagram,XandYouTube.求人内容※The expected offer grade is 15 or 16(Depending on the candidate's experience as well as interview evaluation)PurposeAs a Study Management Associate III, you will be part of a dynamic, centralized studymanagement team that is responsible for the execution of our global clinical trials anda key member of the study team.The Study Management Associate III works as an independent, contributing memberof a cross-functional and global partnership to plan, execute and manage one or morePhase 0-4 clinical trials under the guidance of the Study Project Manager and SMAManager. The Study Management Associate III works to ensure that assigned studiesare executed with quality and efficiency, in accordance with timelines and budget tosupport broader company strategic objectives. The Study Management Associate III isexpected 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 clinicalstudy leader and contributor with appropriate support from the Study ProjectManager 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-functionalenvironment for activities from inception through closure, connecting functional workand strategic work across the global study, including but not limited to:o Supports the Study Project Manager in strategic leadership of the cross-functionalteam through stakeholder engagement and influence to drive deliverables andtimelines, including strategy development, meeting facilitation, and timelydocumentation 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 forone or more external vendors, e.g., central lab, recruitment, imaging, internal andexternal committeeso Recruitment management, including thoughtful review of intelligence data,leadership, cross-functional development, and execution of recruitment strategies andmitigation planning on a global scale from country feasibility through subjectrecruitment and retentiono Leadership of assigned meetings (cross-functional (internal), vendor, and/orinvestigator) and provision of regular updates on study status, e.g., agendadevelopment, minutes curation and filingo 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 studymaterials, including but not limited to:o Protocols, regulatory submissions, patient reported outcome measures, studyexecution plan, informed consent, site budgets and agreements, clinical study report,training materials, newsletters, presentations for various stakeholderso CTMS and eTMF management to ensure compliance/inspection readiness, supporttrend analyses and support timelineso EDC, IRT, and ePRO, which includes review of design specifications, participation inuser acceptance testing, and contribution to development and review of associatedplans and key risk indicators, as well as system management activities like accesssupport, query resolution, and oversighto Management of investigational product and other associated study supplies・ Provide engaging training to identified stakeholders as needed, e.g., study teammembers, vendors・Support global submission strategies・Support process improvement initiatives or serve as a subject matter expert and/ormentor資格• Bachelor’s Degree or OUS equivalent required• Must have at least 4 years of progressive Pharma-related/clinical research-relatedexperience with a high level of core and technical competencies• Competent in application of standard quality procedures (SOP, ICH/GCP, GlobalRegulations)• Experienced user of systems such as EDC, IRT, CTMS, and eTMF• Strong analytical and critical thinking skills to evaluate complex issues from multipleperspectives to actively develop strategies and drive smart decision making to supportacceleration 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 andpersuasive 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 studyexposure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。上記のリンク、またはこの投稿内の第三者リンクをクリックすると、当サイトを離れ、第三者のウェブサイトに移動します。そのサイトでは、第三者の利用規約およびプライバシーポリシーが適用されます。応募してみる応募してみるプライバシー通知
