Global Study Associate Manager 薪资面议
上海-静安区 3-5年 本科
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TAq Specialist · 阿斯利康
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职位介绍
The GSAM is a member of extended global study team supporting delivery of clinical studies within Global Medicines Development (GMD) to time, cost and quality, from Clinical Study Protocol (CSP) development through study set-up, maintenance, close-out, development of Clinical Study Report (CSR) to study archiving. The GSAM works cross-functionally with internal and external partners to deliver delegated aspects of the clinical study in accordance with Global Study Leader (GSL) in delegated aspects of clinical study execution in accordance with the Study Team Operating Model (STOM), AZ Project Management Framework, current clinical trial regulations (e.g. ICH GCP), AstraZeneca Standard Operating Procedures (AZ SOPs), AZ policies and best practices (e.g. AZ guidelines) and in line with AZ values and behaviours. • In partnership with AZ enablement team, other AZ clinical experts and external service providers, the GSAM provides oversight to ensure study delivery. • Leads/contributes to the preparation of delegated study documents (e.g. Informed Consent Form, master Clinical Study Agreement etc), and external service provider related documents (specifications, study specific procedures, descriptions, presentations etc.) • Maintains and facilitates interactions with internal functions including but not limited to Enablement, Data Management, Procurement, Regulatory, Patient Safety and Quality Assurance, and external functions including the CROs and other external service providers to ensure an efficient study delivery to time, costs and quality objectives • Contributes to the planning and conduct of internal and external meetings (e.g. Investigators’/Monitors’ meeting) • Ensures the supply of Investigational product and study materials by liaising with Clinical Supply Chain or external service providers as appropriate • Proactively contributes to risk and issue identification, development of mitigation and/or action plans for identified risks and issues • Ensures that all study documents in scope of GSAM’s responsibilities are complete and verified for quality in Trial Master File • Supports Global Study Leader (GSL) with budget management, such as external service provider invoice reconciliation • Adheres to global clinical processes, procedural documents, applicable Quality & Compliance manual documents and international guidelines such as ICH/GCP to ensure study is inspection ready at all times • Supports Global Study Leaders (GSL) in project management as per agreed delegation • For outsourced studies, supports Global Study Leader (GSL) in management of the CRO Project Manager to ensure study delivery according to agreed timelines, budget and quality standards, while ensuring that the appropriate level of oversight of the CRO is maintained and documented throughout the lifecycle of the study, in accordance with relevant AZ SOPs and guidelines (e.g. description of services and transfer of obligations) • Take on assignments on non-drug project work in process improvements and/or leading improvement projects as discussed and agreed upon with their manager Essential: • University degree (or equivalent), preferably in medical or biological sciences or discipline associated with clinical research. • Relevant experience from within the pharmaceutical industry or similar organization or academic experience, preferably of at least 3 years. • Knowledge of clinical development / drug development process in various phases of development and therapy areas • Excellent knowledge of international guidelines ICH/GCP • Excellent communication and relationship building skills, including external service provider management skills • Good project management skills • Demonstrated ability to collaborate as well as work independently • Demonstrated leadership skills • Computer proficiency, advanced computer skills in day-to-day tasks • Excellent verbal and written communication in English Desirable: • Advanced degree • Experience in all phases of a clinical study lifecycle • Basic knowledge of GXP outside of GCP (i.e GMP/GLP AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised. 阿斯利康是一家提供平等机会的企业,我们将考虑所有符合条件的求职者就业。不因残疾、性别或性取向、怀孕或产假状况、种族或民族或族裔出身、年龄、宗教或信仰、性别认同或变更、婚姻或伴侣关系、受保护的退伍军人身份(如果适用)及任何其他受法律保护的特征而产生歧视。
其他信息
语言要求:英语、普通话
所属部门:Development Operations

公司简介

2023年是阿斯利康进入中国的第三十年。自1993年以来,阿斯利康始终秉持“以患者为中心”的初心,以科学为本,不断开拓科学疆域,从药物研发、生产运营、商业模式等领域不断推动创新实践和可持续发展。三十年来,阿斯利康始终致力于成为一家“引进来、扎得稳、走出去”的本土化跨国药企,凭借其全球优势资源与对中国本土医药市场的深度洞察,持续汇聚全球智慧力量,同时不断助力“中国创新”走向全球,实现“植根中国,服务中国,惠及全球”的长期承诺。 阿斯利康中国总部及全球研发中国中心位于上海,并在无锡、泰州、青岛分别建立全球生产供应基地,已向约70个全球市场输送优质药品。截至目前,公司在华累计投资近20亿美元*,近年来分别在北京、广州、杭州、成都、青岛设立区域总部。三十年来,阿斯利康始终聚焦中国患者亟需的治疗领域,包括肿瘤、心血管、代谢、肾脏、呼吸、消化、罕见病、疫苗抗体及自体免疫等,已将近40种创新药物带到中国。 深耕中国三十载,阿斯利康持续看好中国研发及创新实力,不断加大部署与投资,持续在中国提升研发创新的速度和高度。2002年阿斯利康率先在中国进行全球多中心临床试验;2007年在华投资建立中国创新中心,聚焦中国患者未被满足的健康需求;2013年成立中国新药研发部以支持阿斯利康创新药物在中国的临床开发和上市;2017年阿斯利康与国投创新合资成立迪哲(江苏)医药有限公司,加快本土新药研发步伐;2019年升级新药研发部为全球研发中国中心,并于2021年在上海正式启用,深度参与全球研发,以强劲的中国研发实力积极助力全球新药研发步伐,目前中国研发管线内有180多个项目,关键项目与全球同步研发率达100%,计划5年内在中国至少引入15款新药(NME),获批新药或新适应症可达80个左右。同时在中国尚存在巨大医疗需求的疾病领域进行前瞻性布局;携手助力中国本土创新走向全球,加速中国产生优质的创新药惠及更多患者。 阿斯利康与产业共生共荣,携手政、产、学、研、医、投等跨界力量,以明晰的规划布局,以创新驱动发展,通过打造包括中国智慧健康创新中心(CCiC)、国际生命科学创新园(iCampus)、阿斯利康中金医疗产业基金在内的创新“三驾马车”,构建多元化的国际创新健康生态圈,共同促进区域经济以及大健康行业的长足发展。目前,中国智慧健康创新中心支持打造的诊疗一体化创新模式,已落地全国数千家医院,部分方案还走出国门落户全球更多国家和地区;国际生命科学创新园结合各地产业优势,打造一站式赋能平台,已形成覆盖全国多地协同的生命科学创新生态网络,并迎来110余家海内外企业入驻;阿斯利康中金医疗产业基金目前在管资金已超30亿元,并成功投资近20家企业,2022年基金还开启区域布局新篇章,穿越周期、跨越地域为中国创新提供多维赋能。 作为连续十三年的杰出雇主,培养本土化人才始终是阿斯利康在中国长足发展的基石。我们积极开发海内外、跨领域的人才发展项目,树立“科学为本、患者至上、志在必得、赢之有道、开拓进取”的企业价值观,为培养具有全球视野、追求卓越、开放合作、勇敢无畏的多元本土创新人才提供无限可能。同时,阿斯利康在中国也高度践行企业社会责任,积极投身多元公益,共促人类、社会及地球的绿色可持续发展。 站在三十而立的新起点,阿斯利康仍将全力以赴、跃行致远,不断深化在华投入,积极发挥国际桥梁作用,“引进来”与“走出去”并举,惠及中国乃至全球,合力擘画全人类的健康蓝图!
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