长沙招聘

职位描述：
Main Responsibilities：
Phase IV Clinical trial and PMOS
Responsible for execution and management for Phase IV Clinical trial (Affiliate or Area/Affiliate Funded) which including Post Marketing Observational study(PMOS) and interventional studies using Abbvie product as investigational drug.
- Site Management : Screening and selection of sites and investigators .
- Develop Site patient recruitment Reports
- Budget management: Responsible on financial expenses together with Budget planning and phasing.
- Contract Management : Responsible for the contract preparation and negotiation, finalization and signature with hospitals and institution.
- Insurance and subjects AE compensation in clinical trial as needed.
- Study drug packaging and distribution management as needed.

Investigator Initiated Studies and other programs
Responsible for Sponsorship qualification, contract negotiation/signature and Payment/Study Drug Packaging /shipment schedule for Investigator Initiated Studies. Provide Abbvie Support to the sponsor on the EC approval and regulatory submission as needed.
Responsible for other data generation projects from qualification assessment to contract negotiation/signature and payment schedule.
Responsible for Research grant, third party studies, In vivo/in vitro assessment, contract negotiation and payment schedule.

Vender Management and Sourcing
Responsible for vender qualification assessment with QA team, contract, performance management and payment according to Abbvie relevant policies and procedures.

Documentation , System and Compliance
Archiving all the essential documents cross the program life cycle in required systems and format, such as TMF and SharePoint, ensure the access control and version control and information security.
Ensure all the Abbvie information assets including electronic database in Service providers are compliance and security. Archive the database within Abbvie after the project completed.

Quality, Audit/inspection and Internal Collaboration
Ensure that all activities and interactions are conducted with due regard to all applicable local, global and national laws, regulations, guidelines, codes of conduct, Company policies and accepted standards of best practice.
Work with relevant functions with Global, Regional and china to ensure the program quality control and no critical findings from internal audit both in Clinical trial operation and information security.


Requirements：
Bachelor or advance degree in clinical medicine or Pharmacology, qualification on GCP.
Minimum of 1 years of clinical trial experience in the Pharma or CRO as CRA.
Good communication skills in English and Chinese. 举报 分享

关于艾伯维中国

艾伯维（纽约证交所:ABBV）是一家于2013年1月2日正式成立的全球研究型生物制药公司，从雅培公司拆分而来。 艾伯维将尖端生物科技与百年传承的专注、激情，以及专业技术和组织架构集于一身，凭借其专业技术、敬业的员工和独特的创新方式，旨在研发并推广先进治疗方法，解决世界范围内的一些疑难杂症。2013年，全新成立的艾伯维在全球范围内拥有近21,000名员工，产品销往170多个国家。

艾伯维已在中国正式注册成为一家外商独资的医药公司,并且于2013年6月1日完成与雅培中国的拆分。艾伯维中国的产品线涉及多个疾病领域，涵盖免疫学领域、抗病毒学领域、肾脏学领域以及麻醉学领域。同时，艾伯维与中国的医学界和政府部门紧密合作，共同开展覆盖丙肝、肿瘤、免疫学、神经科学、疼痛和妇科健康等领域的临床研究。

艾伯维中国介绍

中国总部    上海

研发中心    艾伯维中国研发中心——上海张江研发中心，落成于2009年3月，是艾伯维全球7个研发中心之一。作为临床前研究的一环，支持全球药品研发中心（GPRD）的药物研发，主要集中在免疫、疼痛、神经系统与肾病领域。

员工数    近500名

历史 艾伯维中国成立于2013年6月1日

企业评级

艾伯维被纳入标准普尔500红利经典指数（S&P 500 Dividend Aristocrat Index） ，纳入这一指数的标准是公司股票连续25年以上实现持续增长的现金分红。同时， 艾伯维也被纳入标准普尔高产红利经典指数（S&P High Yield Dividend Aristocrats Index） ，纳入这一指数的标准是连续20年以上实现持续增长的现金分红。

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