上海康德弘翼医学临床研究有限公司

  • 所属行业:其他
  • 企业规模:501-1000人
  • 企业性质:民营/私营企业

Data Manager 临床数据管理员(湖北总部,数据管理部)

  • 工作地点:武汉
  • 有效日期:2017年07月13日 至 2017年10月20日
  • 招聘人数:多人
  • 职位性质:全职

Data Manager 临床数据管理员 职位描述:

职位概述:按照要求提供数据管理方面的专业知识,参与所分配项目中与数据管理相关的服务。
主要岗位职责:
协调临床数据管理过程,保证临床研究数据的及时性、真实性、准确性和完整性;
进行病例报告表数据的日常检阅以及质疑表的处理;
实施数据录入以及数据的双份录入和一致性比对;
按照数据核查计划核查数据,对可疑数据发布数据质疑表,解决数据质疑,并更新数据库;
为临床研究方案的设计提供数据管理支持和审阅;
参与数据管理计划、核查计划等相关文档的撰写和审阅。

Position Purpose
?Responsible for ensuring the completeness, quality and integrity of the subject data in the clinical trial database.
?Ensure the consistent use and application of applicable data standards. The ultimate objective is to ensure data quality and consistency across programs and repositories.
?Responsible for data management activities within a clinical trial, according to regulations, applicable Standard Operating Procedures (SOPs) and Processes.
?Works with the global study team to meet the study objectives.
Primary Responsibilities
General
?Ensure that all data components are conducted in compliance with GCP, relevant SOPs, and regulatory requirements.
?Ensures Conformance to Pfizer Data Standards.
?Actively participates in monthly project review meetings.
?May participate in Therapeutic Area (TA) specific process improvement initiatives.

Hands-on data management responsibilities (Data Manager):
?Create and implement the Data Management Plans (DMP) to ensure data completeness and accuracy.
?Set-up and test data review listings to verify the quality and completeness of data as specified in DMP.
?Ensure timely set-up of clinical data acquisition and management tools and data validation.
?Maintain study tracking to ensure timely CRF retrieval, data entry 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.
?Ensure integrity of clinical data and update database by issuing and resolving DCFs as necessary.
?Reconcile the patient database with the Serious Adverse Event database.
?Document all efforts of data management and file all responsible documents.

Technical Skill Requirements
?Demonstrated knowledge of clinical development process including knowledge and understanding of the principles of GCP
?Demonstrated knowledge of data management processes and principles in area of responsibility.
?Works independently, receives instruction primarily on unusual situations
?Ability to organize tasks, time and priorities; ability to multi-task
?Ability to communicate effectively and appropriately with internal & external stakeholders, locally and globally
?Ability to work in ambiguous situations within teams to identify and articulate complex problems
?Demonstrated knowledge of clinical development and regulatory submission processes and requirements.
?Knowledge/proficiency/understanding of technologies to support data acquisition, computerization and data validation, computer systems life cycle technology
?Strong understanding of the state-of-the-art technologies to evaluate and leverage them into improved business processes for worldwide deployment and adoption.


Qualifications
?Bachelor degree or equivalent in a natural/medical science, data management or related discipline.
Preferred Additional Experience
?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, DMPs and data cleaning activities
?Knowledge of clinical trial database and its applications
?Knowledge of Windows Environment and its applications (Word, Excel, PowerPoint, Project, etc.) 

上海康德弘翼医学临床研究有限公司其他最新招聘

职位名称 工作地点 职位类型 发布日期 所属机构
Data Manager-Japanese 临床数据管理员-日语方向 上海 全职 7月31日 战略方案解决部
临床统计编程员 SAS Programmer 武汉 全职 7月13日 湖北总部
SAS programmer 上海 全职 7月13日 湖北总部

公司简介

康德弘翼(WuXi CDS)是全球领先的医药研发服务平台(CRO)药明康德(WuXi AppTec)集团的全资子公司。我们为药品,生物制品和医疗器械等医药产品提供全方位的I 至 IV期临床研究服务。