天津招聘

Responsibilities
辉瑞（武汉）研发中心向社会公开招聘临床数据管理员40名（工作地点：武汉）

（如果您符合以下任一要求，并有兴趣在生物制药行业全球领先的辉瑞公司武汉研发中心开拓职业发展机会的话，欢迎您第一时间申请我们的岗位）我们希望符合以下条件之一的投寄简历。
1.现在已经是临床数据管理员，或从事临床研究工作；
2.具有医学，药学，或相关的学历（如护理，公共卫生等）
3.现在的工作和背景能胜任临床数据管理员。

数据管理员的工作语言是英语，主要职能是：
1.CRF（Case report form）设计和使用数据库及系统
2.Data Management Plan (DMP) 制定
3.负责收入的临床研究数据清理和提供报表
4.临床研究档案管理

Position Purpose
*The Data Manager is responsible for ensuring the completeness, quality and integrity of the subject data stored within the clinical trial database.
*The Data Manager is responsible for data cleaning aspects of the data management role within a clinical trial, according to Pfizer Standards, Processes and Standard Operating Procedures (SOPs).
*The Data Manager works with the global study team to meet the study objectives in the release of databases.
*The Data Manager will ensure the consistent use and application of standards. The ultimate objective is to ensure data quality and consistency across programs and repositories.


Organizational Relationships:
*Directly reporting relationship to DM TA Lead or Team Lead in CDS
*Strong partnerships with Lead Data Managers (LDM), Project Data Management Leads (PDL), and Data Base Managers (DBM) within Pfizer
*Partnership with other related functions in study teams as needed.


Primary Duties:
General
*Ensure that all data components are conducted in compliance with GCP, relevant SOPs, and regulatory requirements.
*Ensures Conformance to Pfizer Data Standards or designated data standards.
*Actively participates in monthly project review meetings.

Specific:
*Create the Data Management Plan (DMP) for completeness and accuracy, including the Data Flow Activities Document, CRF Completion Guidelines, Data Quality Specification (Edit checks), Data Listing Documents, Data Handling Conventions (Permissible Changes), Data Quality Control Plan and Data Entry Guidelines.
*Set-up and test data review listings to verify the quality and completeness of data as specified in the Data Quality Specification (Edit checks) document.
*Ensure timely set-up of clinical data acquisition and management tools and data validation.
*Maintain a Study Tracking Spreadsheet to track the progress of CRF retrieval, data entry of CRFs and data cleaning activities.
*Perform data cleaning activities including discrepancy management (review of errors from electronic checks) and review of data listings to verify quality and completeness of data and issue Data Clarification Forms (DCFs) as necessary to seek further clarification from sites.
*Ensure integrity of clinical data and update database with resolved DCFs as necessary.
*Reconcile the Serious Adverse Event (SAE) data between patient database and the safety database.
*Document all efforts in the cleaning and release of the database.
*Ensure filing of all clinical trial documentation to the Trial Master File.

Training & Education Preferred:
*Bachelor's degree or equivalent in a natural/medical science, data management or related discipline.
*Fluent English both in reading and writing.

Prior Experience Preferred
*Working knowledge of clinical development process, understanding concepts of Phase I-IV and principles of study design.
*Previous experience within a data management role, understanding key processes and principles associated with role including CRF design, database set-up, edit check specification, DMP and data cleaning activities.
*Knowledge of Windows Environment and its applications (Word, Excel and PowerPoint, Project, etc.).

GSK is an equal/opportunity affirmative action employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.
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