研究管理专员 III/CTM III
Associate, Study Management III/CTM III
关于艾伯维
艾伯维的使命是发现并提供创新药物和解决方案，解决当今严重的健康问题，并应对明天的医疗挑战。我们致力于在多个关键治疗领域产生显著影响，包括免疫学、肿瘤学和神经科学，以及我们Allergan Aesthetics产品组合中的产品和服务。有关艾伯维的更多信息，请访问我们的网站www.abbvie.com。关注LinkedIn、Facebook、Instagram、X和YouTube上的@abbvie。
作为研究管理专员III，您将加入一个充满活力的集中式研究管理团队，负责执行我们的全球临床试验，并成为研究团队的重要成员。
研究管理专员III将在研究项目经理和研究管理经理的指导下，作为跨职能和全球合作中独立且有贡献的成员，负责计划、执行和管理一项或多项0-4期临床试验。研究管理专员III需确保所分配的研究按照时间表和预算高质量高效地执行，以支持公司更广泛的战略目标。研究管理专员III需遵循所有艾伯维的工作方式。
这是一个全球职位，可能为远程办公。
职责
· 研究管理专员III需在研究项目经理的适当支持下，作为临床研究负责人和贡献者独立工作，完成以下符合质量标准（ICH/GCP、全球法规和艾伯维政策及程序）的活动：
· 在跨职能环境中对一项或多项全球试验进行研究层面的监督和领导，从启动到结束的各项活动，连接全球研究中的职能工作和战略工作，包括但不限于：
· o 通过利益相关者参与和影响力，协助研究项目经理进行跨职能团队的战略领导，推动交付成果和时间表，包括策略制定、会议主持和及时的文档记录，以推动临床试验的及时执行
· o 供应商管理，包括请求提案（RFP）/启动、选择、工作范围开发与审查、交付成果监督和风险管理工作，针对一项或多项外部供应商，例如中心实验室、招募、影像、内部和外部委员会
查看英文原文
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.
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. 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
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join-us/reasonable-accommodations.html