Technical Operations Lead
辉瑞制药有限公司
- 公司规模:5000-10000人
- 公司性质:外资(欧美)
- 公司行业:制药/生物工程
职位信息
- 发布日期:2014-04-21
- 工作地点:武汉
- 招聘人数:1
- 学历要求:本科
- 职位类别:临床数据分析员
职位描述
Position Purpose
- Technical Operations Lead (TOL) provides technical leadership and management in assigned functional areas, including but not limited to: Study Start Up, Electronic Data Handling; Acquisition & Processing for Lab Data and PK/PD Data; Data Extract and Listing, Data Visualization; Coding; and training, etc.
- Accountable of delivery functional area goals, motivate and inspire staff, ensure alignment to agreed global and local Dev Ops strategic directions
- Create, maintain and assume accountability for a culture of high customer service using tools to facilitate communication, transparency of operations, clarity of workload balance, and alignment
- Identify, lead and support strategic initiatives within CDS to enhance operational efficiencies using systems and systems enabled processes.
- Collaborate with other Technical Processing Team Leads to develop and maintain a support model and to facilitate issue resolution and capture corrective actions; and to ensure operational efficiencies such as resource sharing, staff development, and sharing of best practices across work areas, functions and sites.
- Participate with other CDS Management and key customer leads to facilitate the delivery of services and effectively manage the coordination of services across specific process areas.
Organizational Relationships:
- Direct reporting relationship to Wuhan CDS Head; dotted line reporting relationship to TOL in CDS Shanghai
- Directly manages WCDS technical operations staff
- Strong Partnerships with key customers and other function leaders at all sites
Resources Managed (FTEs):
- Group consists of Pfizer headcount and contractors (this may vary depending upon workload requirements).
- Works closely with study teams and manages relationships with electronic data vendor/ service providers at study level.
Primary Duties:
Process and Standards
- Participate in standard forums (i.e., OPD zones, CDS initiatives, etc.) to further standardize and optimize CDS’s processes and practices
- Actively identify continuous improvement opportunities to enhance operational efficiencies through process and metrics analysis
- Participate and lead efforts to training as it relates to the technology-enabled clinical trial processes
- Promote the use of consistent, efficient, and quality processes to meet timelines and deliverables
Customer Outreach
- Plan and execute communication plans & methods for engaging customer populations (e.g., newsletters, websites, user groups)
- Interface with customers on solutions, requirements, continuous improvement, deployment change management, user groups and workshops, etc
- Understand customers and stakeholders and ensure they are satisfied with support services and systems
- Build & maintain knowledge-base (e.g., FAQ)
- Communicate key project status and to various levels within the organization
Implementation
- Implement business strategies and technology-enabled processes and tools in close partnership with appropriate groups in CDS
General
- Provide administrative and technical oversight of group
- Develop people, including recruitment, retention, and career development and performance management
- Able to resolve conflicts, influence and communicate with key stakeholders and user groups
- Collaborate with key departments
- Support rapid response, audit and inspection needs
Training & Education Preferred:
Bachelor’s degree or above of equivalent experience in a scientific discipline required
Prior Experience Preferred
- Technical expertise and business process support in systems supporting clinical trials (document management, data acquisition, data management, trial management, reporting, etc)
- Thorough understanding of the processes associated with clinical study management, data management, and regulatory operations
- Leadership, project management, resource management (staff), administrative, and technical capabilities are required, as well as effective verbal and written communication skills in relating to colleagues and associates both internal and external to the organization.
- Demonstrated project management skills (multiple complex projects)
Technical Competencies
Competency Detail / Comments (specific skills, etc.)
Project Management · Demonstrated ability to lead multiple projects
Process Development · Proven ability to define clear, streamlined processes for technologies supporting clinical trials
Clinical Trial Processes · Demonstrated knowledge of clinical development process including in depth knowledge and understanding of the principles of GCP
Systems Technologies · Knowledge/understanding of technologies to support clinical trials, familiarity with software lifecycle.
- Strong understanding of the state-of-the-art technologies to evaluate and leverage them into improved business processes for worldwide deployment and adoption.
Communication/Influencing Skills · Understand customers and stakeholders and adapt messages appropriately
- Proven ability to communicate difficult messages to various levels within the organization.
Decision Making · Ability to make complex decisions that require choosing between multiple options
Problem Solving · Ability to work in ambiguous situations within the team to identify and resolve complex problems
Data Management Expertise · As applicable: Extensive knowledge of data management processes and principles in the specialty: CRF Design, Oracle Clinical Data Base Development, Randomization, Data Loading, EDC, e-Diaries, CRF Processing, Submission Assembly or Validation Procedures
Organizational Skills · Working knowledge of the principles and concepts of other disciplines
- Works independently and receives instruction primarily in unusual situations
- Ability to organize tasks, time and priorities of self and others; ability to multi-task
Pfizer Senior Leader Core Competencies
Competency Detail / Comments (specific skills, etc.)
- Customer Focus
- Collaborative, Teamwork
- Influencing
- Networking and Alliance Building • Demonstrated ability to understand customer perspective and deliver solutions that meet expectations
- Demonstrated ability to collaborate and negotiate across business lines to reach a common goal
- Works cooperatively with key internal and external stakeholders to ensure success
- Ability to successfully negotiate decision making
- Identifies possible synergies and actively pursues partnerships
- Proven ability to establish new partnerships
- Courage with Decisiveness to Act
- Learning Organization
- Flexibility and Resilience · Respectfully challenges practices, decisions or ideas to uphold integrity and ethical standards
- Engages in appropriate experimentation, risk-taking and development in all aspects of work
- Explores new methodologies for application to business challenges
- Responds to changing situations and others’ ideas that differ from own positively and constructively
- Personal Leadership · Demonstrates contributions to the achievement of business objectives; services as an advocate for others
- Consistently takes and encourages actions that are new or that improve existing approaches and systems
- Takes initiative to progress projects and tasks
- Consistently provides constructive input
简历收集邮箱:job-c2.china@pfizer.com
公司介绍
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.
联系方式
- Email:chinahrwest@Pfizer.com
- 公司地址:南京西路中信泰富