南京招聘

工作职责:

Role Summary

As part of the Data Monitoring and Management group, an integral delivery unit within the Global Biometrics and Data Management (GBDM) organization, the Asset Lead is responsible for timely and high quality data management deliverables supporting the Pfizer portfolio.  Responsibilities include delivery of asset level information strategies and services for optimal use and reuse of internal and external information that will advance research, development, and commercialization of the Pfizer portfolio and further precision medicine. The Asset Lead is expected to manage large or several smaller assets and may directly or indirectly design, develop, and maintain key data management deliverables used to collect, review, monitor, and ensure the integrity of clinical data, oversees application of standards, data review and query management, and is accountable for quality study data set release and consistency in asset/submission data. The Asset Lead may have direct reports.

Role Responsibilities

? As needed, serve as Clinical Data Scientist & Trial Lead for one or more clinical trials assuming responsibility for all DMM activities including selection and application of data acquisition standards, Data Management Plan, selection of quality risk indicators, third party study data due diligence

? Act as the key scientific and technical data management expert; may define and drive the data management strategy and standards for the Therapeutic Areas (TA) as well as RBM standards, tools, data provisioning, and reporting 

? Ensure work carried out by or on behalf of DMM  is in accordance with applicable SOP’s and working practices.

? Serve as Subject Matter Expert (SME) for and oversees the design, documentation, testing and implementation of clinical data collection tools, both CRF and non-CRFs using and electronic data capture (EDC) system and/or other data collection systems.  

? Data Integrity planning and ongoing monitoring of conformance of data quality to plan over multiple assets, through the implementation of customize central data monitoring strategies using appropriate tools and analytics.

? Execution of clinical study data due diligence for acquisition/in-licensing and co-development deals, and clinical research collaborations as required.

? Key data management contact for regulatory inspections/audits in liaison with the appropriate Quality and Safety groups with Pfizer.

任职资格:

Qualifications

? Demonstrated successful experience in all relevant clinical data management activities in a BioPharmaceutical or CRO setting

? Working knowledge of all phases of clinical trials and ability to assess and determine study requirement from protocol review

? Strong Project and Risk Management

? Minimum 10 years Data Management experience required including 5+ years  team leadership 

? Knowledge of clinical research, FDA & ICH, GCP, GCDMP, and related regulatory requirements 

? Proficient experience using commercial clinical data management systems and/or EDC products (e.g.  Medidata RAVE, Oracle RDC / Inform, etc.) 

? Experience using relational databases (e.g. MS SQL Server, MS Access, or Oracle) and data visualization tools (e.g. Spotfire, jReview)

? Familiarity with MedDRA/WHO-Drug coding 

? Knowledge of risk-based monitoring principles and associated analytics/metrics

? Proven experience in vendor oversight to meet aggressive timelines of high quality data deliverables

? Strong verbal and written communication skills; independently and effectively in multi-study, multi-disciplinary atmosphere in an matrix environment

? Bachelor’s degree required.  Degree in scientific field preferred.  Master’s degree preferred.

辉瑞公司（Pfizer Inc.）创建于1849年，迄今已有160多年的历史，总部位于美国纽约，是目前全球***的以研发为基础的生物制药公司。辉瑞致力于运用创新的科学技术以及全球资源来改善每个生命阶段的健康和福祉。
我们的目标是“不断创新为患者带来能显著改善其健康的药物”。我们的使命是“成为一家卓越的创新型生物制药公司”。
2012年辉瑞公司全年合计收入590亿美元，研发投入78亿美元。辉瑞在全球拥有9万多名员工，59家生产基地，业务遍及全球150多个国家和地区。2012年财富全球500强企业中辉瑞排名126位。
目前辉瑞公司的产品覆盖了包括化学药物、生物制剂、疫苗、健康药物、动物保健品等用于人类、动物和消费者保健等诸多广泛而极具潜力的治疗及健康领域，同时其卓越的研发和生产能力处于全球领先地位。
在人类和动物药品的发现、开发和生产过程中，辉瑞始终致力于奉行严格的质量、安全和价值标准。每天，分布在世界各地的辉瑞员工致力于促进当地医疗卫生的发展以及探索能够应对当今最为棘手疾病的预防和治疗方案。
辉瑞还与世界各地的医疗卫生专业人士、政府和社区合作，支持世界各地的人们能够获得更为可靠和可承付的医疗卫生服务。这与辉瑞作为一家世界领先的生物制药公司的责任是一致的。160多年来，辉瑞一直努力为人们提供更好、更优质的服务。
辉瑞生物制药目前在华上市的创新药物已超过50个，其治疗领域涵盖了心脑血管及代谢、抗感染、中枢神经、抗炎镇痛、抗肿瘤、泌尿、疫苗及等诸多领域。其中如立普妥®、络活喜®、万艾可®、舒普深®、希舒美®、沛儿®、索坦®许多产品在市场上处于领先地位。为了让中国的广大患者能及时接受与全球同步的先进的药物治疗，辉瑞未来将进一步加大和加快在华新药引进和上市的力度和速度。
辉瑞健康药物旗下的善存®、钙尔奇®、惠菲宁®等消费保健产品也在中国市场家喻户晓，并以其优异的品质深受广大消费者的青睐；辉瑞旗下的硕腾动物保健品*为中国的动物保健市场提供各类领先的动物疫苗和动物药品。

At Pfizer, we apply science and our global resources to improve health and well-being at every stage of life. We strive to set the standard for quality, safety and value in the discovery, development and manufacturing of medicines for people and animals. Our diversified global health care portfolio includes human and animal biologic and small molecule medicines and vaccines, as well as nutritional products of healthcare industry and many of the world's best-known healthcare products such as Centrum. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as the world's leading biopharmaceutical company, we also collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 160 years, Pfizer has worked to make a difference for all who rely on us.