莆田招聘

工作职责:

Role Summary:The Senior Study Manager acts as the single point of contact for all responsible studies. The Senior Study Manager has accountability for the study end to end delivery throughout study design, start-up, conduct, analysis& reporting,  study close-out, inspection readiness, submission and regulatory defense for one or more single/multiple countries studies.

The Senior Study Manager is accountable for developing the operational strategy and managing the timelines, budgets, and quality across more complex studies, such as Asian studies, Global studies and studies that do not follow a currently defined model within DC.

The Senior Study Manager is an expert on the operational delivery of clinical trials and brings that expertise to the design & conduct of clinical studies in alignment with the program and portfolio strategies for the specific category (ies).

And Senior Study Manager lead and manage the core cross functional stakeholder for planning and delivery to the Best-in-Class targets as well as optimal resourcing of the study team(s) and ensuring optimal study team(s) health.

The Senior Study Manager is responsible for the line management of junior study manager, Clinical Research Associate (CRAs) to ensure quality, oversight and efficient execution of Pfizer clinical trials within the country/region in accordance with Pfizer standards, applicable laws and business needs.

The Senior Study Manager is responsible for monitor site performance using appropriate tools and resources (e.g. metrics, site health, Risk Based Monitoring signals etc.) and take appropriate targeted action.  Conducts risk assessments to identify actions for mitigation and control across studies. And conduct and report oversight activities, both remote and onsite visits according to Pfizer standards.

任职资格:

Qualifications (Training, Education & Prior Experience):Minimum of BS/BA in a biomedical discipline or equivalent education/training is required

At least 7 years in clinical practices

Good working knowledge of Good Clinical Practices (GCPs), monitoring, clinical drug development process and country regulatory environment

Experience with clinical research methodology (e.g., study design, study monitoring and data

analysis). Prior study management and/or study coordination experience preferred.

Demonstrated effectiveness in working in a multidisciplinary, matrix team situation.

Effective verbal and written communication skills in relating to colleagues and associates both inside

and outside the organization.

Advanced education and/or training/experience desirable.

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.