蚌埠招聘

Role Description
Leads the study management function to ensure quality, timely, oversight and efficient execution of Pfizer clinical trials within the country/region as appropriate in accordance with Pfizer standards, required regulation and business needs. Provides line management to Study Mangers (SMs) with respect to colleague development, performance management, and colleague engagement. Aligns with Clinical Research, Business Unit, New Product, Regulatory to ensure alignment with China strategies.
Responsible for the study management under guidance of Head of Clinical Development & Operations to:
- Lead the Study Manager (SM) to secure the study management in line with China strategies
- Ensure overall quality and compliance of all China studies
- Coach, develop and direct performance of the SM to achieve business goals and optimize overall effectiveness
- Develop and maintain constructive relationships with the assigned BU team to facilitate teamwork, communication, strategic alignment and development of business opportunities that enhance the conduct of clinical trials
- Contribute to the elaboration and implementation of strategic direction and initiatives of the country /region leadership team
- Ensure efficient planning and prioritization in liaison with the Clinical Project Management
- Develop and execute individual development plan to enhance performance of team development and retention
- Coordinate local resources, such as SMs as necessary to support execution of protocols
- Demonstrate leadership to support the SM to maintain sound Investigator relations
- Responsible for TA or BU alignment

Responsibilities
Study Manager Management Interface
- Leads the study management team
- Monitors the team progress through metrics stakeholder feedback and project timeline
- Provides continuous development of management and leaderships skills of direct reports through delegation tasks, projects and ongoing coaching and feedback
- Models Pfizer Leader behaviors and Values through day-to-day interaction
- Optimizes team effectiveness by overseeing study management responsibilities, process improvement initiatives and promotes a culture of continuous quality and efficiency assessment
- Ensures appropriate and timely training as per training curriculum
- Develops Individual Development Plan (IDP) that identifies knowledge and skills gaps based on business and career goals
- Achieves individual development plan
- Transfers acquired knowledge and skills to achieve goals on the job

2. Clinical Project Management (CPM) Interface
- Ensures a SM Point-of-Contact for CD&O for assigned protocol
- Ensures the local activities to meet study objectives/milestones
- Ensures support for project team need in preparation of Investigator meeting if required
- Ensures availability of the training materials from project team
- Ensures the communication of various progress reports which identify and address study progress and quality issues

3. Country/regional Project Management
- Secures and coordinates through the SM all the country/regional study management aspect such as:
-Review of Monitoring Visit Reports
-Protocol feasibility and Site Selection
-Study Start-up Activities
-Study Conduct
-Regulatory/Ethics/Health Authority responsibilities
-Inspection Readiness, Compliance and Audit Responsiveness
- Measures, monitors and forecasts study management workload
- Implements efficient study management sourcing strategy
- Oversees commitments to clinical trial deliverables (e.g. CMA)
- Identifies, facilitates and /or oversees process improvement initiatives related to study management responsibilities

4. Partnership development and consolidation
- Collaborates with BU partners to understand clinical development strategies, opportunities and needs to ensure that the clinical studies are appropriately conducted, resourced and necessary skills developed to support the clinical trial management
- Develops new business opportunities by identifying new clinical trials through liaison with local BU and also with relevant global partner
- Ensures efficient knowledge transfer of BU program strategies and expectations to the site management team

Qualifications
Training and Education Preferred:

A scientific or technical degree in the healthcare area is preferred along with extensive knowledge of clinical trial methodology. In general, candidates for this job would hold the following levels of education/experience:

- BS/BSc/MS/MSc or equivalent + 8 years of clinical research experience
- Ph.D./MD or equivalent + 4 years of clinical research experience

Prior Experience Preferred:

- Extensive knowledge of clinical development processes with strong emphasis on monitoring and study management
- Extensive leadership experience
- Site Management/Monitoring (CRA) experience
- Project management experience in the clinical development area
- Ability to lead, troubleshoot and influence for delivery

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.