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Data Management Specialist

The Programme

我们是目前中国生物医药企业中研发投入最多的企业

创造的力量、创新的科学氛围,以严谨逻辑解决问题的原则,跨学科团队协作,以及贯穿整个研发环节的对卓越品质的追求,是帮助我们实现所有成功的重要因素。

Responsibilities

  • Lead studies within a program
  • Oversee data managers working on studies either in-house or CRO/FSP resources
  • Serves as active member of Clinical Study Teams
  • Collaborates with other functions to develop timelines and ensure that clinical data management deadlines are met
  • Defines external data transfer specifications and works with external vendors in support of timelines and data-related deliverables
  • Ensures process is in place to review and reconcile lab data with lab normal ranges
  • Develops or oversees development of eCRF and edit check specifications as necessary to support data collection and analysis required by the protocol
  • Works closely with database builders during programming of EDC databases, edit checks and reports
  • Drives and performs User Acceptance Testing (UAT) activities for clinical trial database build and modifications
  • Develops or oversees development of study-specific eCRF Completion
  • Guidelines and Data Management Plans Creates and maintains data management documentation
  • Ensure data cleaning activities as specified in the Data Validation Specifications and Data Management Plan
  • Works with coding group to ensure coding is applied to assigned clinical studies in conjunction with study timelines and deliverables
  • Defines listings in support of data management, clinical and medical review of data
  • Identifies and troubleshoots operational problems, issues, obstacles, and barriers for studies based on metrics data, audit reports, and input from other project team members

Required Skills and Abilities

  • Bachelor’s degree , no special major limited
  • Oncology experience preferred
  • Ability to work in cross-functional team-oriented environments
  • Understanding of ICH and regulatory environment as it pertains to data management
  • Experience with SDTM/CDASH.Strong project management skills
  • Excellent written, verbal and organizational skills
  • Must be detail-oriented
Closed a year ago
Closed a year ago
  • Job type:Graduate Jobs
  • Citizenships:

  • Locations:

    Wuhan (China)

  • Closing Date:21st Mar 2019, 6:00 pm

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