南京招聘

Responsibilities
Position Title: Registry Quality Control Head
Zone / Line: WRDC/CRDC
Location: Wuhan/ Shanghai, China
Career Ladder (Level):

Position Purpose
Pfizer’s Corporate Clinical Trial Registry (referred to as the Registry) is the definitive reference catalog of Pfizer sponsored studies, study associated regulatory events, and study sites.
The Registry Quality Control Group Lead manages staff responsible for critical functions related to ensuring the integrity of the Registry. Functions include management of Quality Control and data entry workload and the monitoring of metrics and policies/procedures for all Registry data attributes. This includes running Quality Control reports; review of potential data quality issues; entry, modification or deletion of data attributes; quality metrics collection; day to day operations and management of associated staff. The Registry Quality Control Group Lead will also create, maintain and assume accountability for a culture of high customer service using tools to facilitate communication, clarity of workload balance, and alignment within and across functional lines.

Organizational Relationships
• Reports directly to the Head of Wuhan Research and Development Center, or the TMF Processing Center Manager, or the Information Analyst Manager
• Dotted line reporting relationship to the Registry Business Process Owner
• Liaises with the Registry Quality Control Lead

Primary Duties
• Supervise the departmental staff in the daily management of Quality Control Reports. Organize and prioritize daily workload for review of the reports and discussion with study teams on needed corrections, as well as data entry into the Clinical Trial Management System (CTMS) as needed.
• Ensure adequate training of staff on Registry/CTMS procedures and policies related to Registry Data Quality guidelines and quality metrics
• Evaluate and implement strategies to ensure consistent processes and procedures for the CTMS application in collaboration with CTMS Council Chair and the Registry Business Process Owner
• Implement organizational design and develop succession planning for group
• Develop people, including recruitment, retention, and career development and performance management
• Review metric dashboards, trending reports and quality sampling reports to understand the overall health of the Registry and identify issues and opportunities for re-training

Training & Education Preferred
In general, candidates for this job would have the following levels of experience:
• Bachelor's degree or equivalent experience in a scientific/business discipline such as Medical, Pharmacology, Clinical, Life Science, Computer Science or English majors required
• Project management, resource management, administrative, and technical capabilities are required, as well as a strong background in managing and leading people. Effective verbal and written communication skills in relating to colleagues and associates both inside and outside the organization.
• Experience with the following applications types is preferred:
• Clinical Trial Management Systems
• Web based data management systems, as required
• Database utilization
• Excellent English verbal and written communications skills, combined with outstanding listening skills are required
• History of achievement in a customer service role with demonstration of meeting customer needs and concerns
• History of achievement in building strong customer relationships
• Experience supporting regulatory submissions and inspections preferred
• Strong skills in negotiation and conflict resolution essential. Ability to remain calm and focused in a high stress situation is very important
• Strong background in provision of high levels of customer service evidenced by positive feedback from customers
• A sound knowledge of working across international boundaries and cultures.

Prior Experience Preferred
• Experience with web based data management systems preferred
• Experience with medical/clinical study records and documentation
• Experience/knowledge of ICH/GCP requirements
• Previous experience leading/managing a group responsible for Clinical Trial Management Systems and/or clinical study management function, or equivalent

简历收集邮箱：job-c2.china@pfizer.com

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.