Data Management Associate I

Gronau Westfalen, NORDRHEIN WESTFALEN | 9 Monate
Diese Position ist möglicherweise abgelaufen!




The Data Management Associate I is an entry level position in the global data management solutions group, learning the tasks required of setting up studies in data collection software systems.

Works in compliance with laws, regulatory agency guidelines, GLP, SOPs and other operating procedures as well as study plans.



Essential Job Duties: 


General Duties


  • Learns to implement study plans into Pristima to ensure internal operational groups’, study direction’s, and the client’s expectations for conducting studies are upheld and to ensure that data entry is facilitated.
  • Learns to use software tools to efficiently and accurately complete job duties. Types of software include word processing, spreadsheet, data collection and tabulation, collaboration/sharing (e.g. Lync®, WebEx®), and database applications.


Study Account Setup


  • (90%) Trains on duties required to setup study accounts in data collection software systems. Tasks to be learned may include, but are not limited to:
  • Learning how to obtain and review study documents (e.g. protocol, amendments) to gather information on pertinent study details
  • Learning to setup and quality check (QCing) study accounts to ensure compliance with study director/client directives and regulatory requirements, when appropriate
  • Learning to update, modify, and correct study accounts with appropriate directive and documentation (e.g. audit trail)
  • Learning to consider peer review comments received
  • Learning to address inquiries from operational staff, complete rush requests, and support various study designs and teams from multiple sites and departments.
  • (5%) Trains on software testing and validation activities. Initial training will include executing test scripts and maintaining documentation in accordance with Covance Unified Systems Life Cycle (CUSLC) methodology which complies with General Principles of Software Validation issued by the FDA.
  • (5%) Performs other duties as assigned.

  • Professional qualification in a technical or commercial field or equivalent.
  • A minimum of English, Maths, and Science GCSEs, but preferably A level or above.

Minimum Required:
  • 3 years of related experience required. Experience with non-clinical studies preferred.

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