Manager Data Management (program DM) 薪资面议
上海-静安区 1-3年 统招本科
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职位介绍
Position manages end-to-end delivery of data management services for assigned projects/studies, collaborating with CROs and other vendors to ensure high quality deliverables are on time and within budget to support drug development processes and global submissions. This position also partners with internal and external stakeholders to optimize Data Management technology, processes, and standards. This position has a working knowledge of Electronic Data Capture/related applications and industry standards, and moderate technical skills in working with data received from CROs and other third party vendors. This position has strong verbal/written skills, analytical, organizational, and interpersonal skills and is able to work effectively with people at different levels and from different disciplines and cultures. Additionally, this position possesses a working knowledge of clinical operations and relevant regulatory requirements. This position has experience working on Phase I-IV studies within the medical device and/or pharmaceutical industry within one or more therapeutic areas. Finally, this position has moderate skills in continuous improvement, project management, change management, and risk management. Responsibilities: 1. Leadership, Direction, and Strategy: 1)Establishes Data Management strategy at the project and/or study level for a smaller number of projects/studies Proactively identifies and manages risks at the project and/or study level for a smaller number of projects/studies 2. Project Management: 1)Plans and directs the conduct of Data Management activities for assigned projects/studies through outsourcing (e.g., study startup, study conduct, study closeout, and reporting). 2)Provides oversight for Data Management CRO and other third party vendors to ensure compliance with the protocol, external/internal standards, Good Clinical Practices (GCPs), applicable regulatory guidelines, Policies, SOPs, and other relevant guidelines. 3)Ensures Data Management deliverables meet/exceed project/study team expectations regarding quality, time, and cost and that Data Management documentation is filed/archived according to applicable Daiichi Sankyo and regulatory requirements. 3. Functional Expertise: 1)Reviews/approves clinical study related documents (e.g., Protocols, Data Management Plan, Clinical Study Reports). 2)Leads and drives the data review process in collaboration with the study team to ensure data quality 3)Participates in audits and inspections. 4.Operational Efficiency / Continuous Improvement: 1)Provides comprehensive data management expertise to project/study teams to optimize study-specific clinical trial processes. 2)May participate in process improvement initiatives. QUALIFICATIONS: 1.Bachelor's Degree and above: in life sciences or related field (or equivalent experience) 2.4+ years in data management and/or related industry work experience in a medical device, pharmaceutical company, or similar environment (e.g., CRO)
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行业要求:全部行业

公司简介

近年来,中国经济的快速成长令世人瞩目,医疗水平也正在不断提升,中国的医药品市场已超越日本成为仅次于美国,并仍在持续增长。近期发布的中国政府报告中,明确提出了“实施健康中国战略”相关部门正在不断深化医疗卫生改革、推进医药市场的健康成长。 中国市场独特的魅力和发展前景吸引了众多外资制药企业纷至沓来,第一三共作为一家具有120多年历史的原研型跨国集团,早在上世纪80年代就开始将众多优秀的原研产品引入中国,并不断扩大在华事业。 作为全球制药公司之一,第一三共已经在中国成功建立了包括研发、生产和销售在内的业务机构 。 第一三共出色的产品品质正不断被业界、患者以及其他用户熟知并认可。这些成绩的取得无一不得益于第一三共人一贯坚持的创新、变革的工作作风。在全球制药业之战进入白热化的今天,第一三共中国不断地突破、蜕变,使我们的中国之旅走得尤为精彩。 市场环境瞬息万变,国家政策不断调整,无论是外资企业还是本土企业都面临着生产研发、商业运营、营销和市场准入等多方面的机遇和挑战。在这个机遇和挑战并存的环境中,我们积极思考、不断调整发展战略。基于环境和政策的特点,我们开展了多元化的合作模式,有效地整合各项资源,在提供优秀药品的同时,不断提供高附加值的产品,积极向肿瘤领域和特殊疾病领域转型,推动新产品上市,以实现“为提高世界各地人们的生活质量作出贡献”的目标。 未来,我们仍将时刻洞悉环境的变化,确立正确的发展战略、组建优秀的员工队伍、提供更专业的学术服务、形成富有竞争力的产品组合,这是我们对中国市场坚定不移的承诺,对第一三共在中国市场的成功我们深信不疑! 第一三共中国始终坚持“Innovation”、“Integrity”、“Accountability”的核心价值,以最高的道德标准来开展业务,不断地追求创新,提供高质量的产品,践行“不断推出创新药物,提供能够满足多种医疗需求的药品,为全球人民的健康和幸福生活作出贡献。”的企业理念。 我们将与中国医药市场共同成长,为中国人民的健康保驾护航,创造新的价值!
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