长沙招聘

工作职责:

Why Patients Need YouPfizer Worldwide Medical and Safety colleagues play a key role in connecting evidenced based, medical decision support with colleagues and stakeholders to enable better health and treatment outcomes. Whether you are creating framework necessary to ensure our evidence is scientifically sound, providing unbiased, medically necessary expertise or investigating how to close gaps in data, our mission is simple. Empower healthcare decisions regarding the safe and appropriate use of medicines for patients.

What You Will AchieveIt is our mission to strengthen the oversight of our clinical data through stronger ownership, control, and visibility of our clinical data. You will play an important role in processing, reviewing, and receiving patient data and records. You will be organizing clinical data forms from therapeutic groups and outside investigators. You will ensure that accurate, timely, and consistent clinical data reaches the medical department and other groups. You will be relied on for data management plans including data preparation, data validation activities, etc.

As part of the Data Monitoring and Management (DMM) group, an integral delivery unit within the Global Biometrics and Data Management organization, the Manager, Project Manager, Clinical Database Management is responsible for the provision of project management leadership and expertise in data monitoring and management with an emphasis on clinical databases and related technologies supporting assigned segments of the Pfizer portfolio. Accountabilities include project management and leadership of the design, development, and maintenance of clinical databases and other technical deliverables within Data Monitoring and Management.  Oversees the development cycle/change control of database build to ensure the integrity of clinical data and the application of Pfizer standards supporting consistency in asset/submission data. Serves as a Subject Matter Expert for database build in the assigned Therapy Area.  The Project Manager, Clinical Database Management works closely with the Clinical Data Scientist to ensure consistent, timely and high quality application of process and delivery of DMM responsibilities. The Project Manager, Clinical Database Management will be accountable to assure process, technologies, and standards are leveraged in a consistent way across assigned projects.  May mentor junior staff members

How You Will Achieve ItWorks closely with department roles, assigned mentor, and cross-functional study team members to manage the development cycle of data capture solutions that support the quality and timely delivery of data required per standard and study specific data review plans.

Solves moderately complex problems related to database build and implementation

May aid with solving problems outside of own department

Oversees operational activities/projects of professional Work Teams to support short-term Department goals.

Leads internal initiatives, working with other roles within DMM to improve processes.  Represents Database Management on DMM initiatives.

Complies with applicable SOPs and work practices

Serve as a project management resource to the study teams for developing and implementing database development project plans.

Ensure proper planning of study activities in DBM and proactively "alert" risk and plan mitigation.

Independently, perform Impact analysis for proposed solutions to existing tools and processes and convey the same to technical and non-technical stakeholders.

Act as an Expert in the area, applying best practices according to documented processes

Participate in Pfizer Standards meetings as appropriate

Ensure compliance always

Ensure seamless functioning and collaboration of DMM activities between the DBM and Clinical Data Scientist functions.

Ensure operational excellence in collaboration with partners and colleagues for application of standards within data capture methods in support of the data review plan, in collaboration with the Clinical Data Scientist, ensure operational excellence across all DMM deliverables

Assess impacts of Change Control and develop mitigation plans for emerging risks and issues.

Identifies existing process/product improvements

Develops innovative, advanced new concepts that improve processes / products across own and related disciplines

Takes appropriate risks to achieve desired result

任职资格:

Qualifications

Must-HaveBachelor

s degree in Life Sciences, Computer Science, or equivalent

Minimum of 5 years of relevant project management experience in a pharmaceutical, biotech, CRO, or Regulatory Agency with an emphasis on building data collection and assimilation solutions

Strong project management, communication (written and oral), decision-making, influencing, and negotiation skills

Familiarity with Electronic Data Capture systems, Clinical Data Management Systems/relational databases (e.g. Oracle InForm and Data Management Workbench, MS SQL Server or MS Access) and data visualization tools (e.g. Spotfire, J-Review)

Experience with MSProject or other enterprise project management tools

Nice-to-HaveUnderstanding of drug development process and data operations required for the reporting of clinical trial data (e.g. data review, study reports, regulatory submissions, safety updates, etc.)

Understanding of regulatory requirements and relevant data standards; CDISC knowledge and experience are preferable

Proficiency in the use of Microsoft Office Suite of tools (Outlook, Word, Excel, etc.)

#LI-PFE 

On October 31, 2005, Pfizer announced the official opening of China Research and Development Center (CRDC) in Shanghai. Pfizer Global Research and Development’s Center is mainly engaged in drug development activities. Much of the facility's capacity is devoted to the study design, data management and statistical analysis of global phase I-IV clinical trials, as well as the clinical study report process. In addition, CRDC is a part of Pfizer global Safety and Risk Management and covers the functions of safety data processing and assessment. The center also trains Pfizer employees in China and throughout the Asia region in internationally recognized Good Clinical Practice standards.
辉瑞公司于2005年10月31日宣布辉瑞中国研发中心正式在上海揭幕。辉瑞中国研发中心主要为全球辉瑞药物开发提供支持工作。大部分的功能是围绕在I-IV期临床试验研究设计、数据管理和生物统计分析、以及临床试验报告的部分准备工作。此外，该中心是辉瑞全球安全和风险管理部的一个分支，负责安全数据处理和评估工作。研发中心还将为辉瑞公司在中国及亚洲的其它运营部门的员工提供国际标准的临床试验管理规范(GCP)的技术培训。