ZOLL Circulation, Inc.

  • Clinical Data Manager

    Job Locations US-CA-San Jose
    Posted Date 2 months ago(12/9/2018 10:45 AM)
    Job ID
    # of Openings
  • Overview

    General Summary:

    Responsible for the creation, updating, maintenance and validation of clinical study databases and for the provision of computerized reports of these data. Assumes the responsibility for management of clinical trials through review, computerization, cleaning and auditing of clinical data and databases in compliance with standard operating procedures, industry and regulatory agency guidelines.


    Essential Functions:

    • Provide data management / data entry / verification / validation / quality control of data collected for worldwide Clinical Trials consistent with applicable regulations, guidelines and policies
    • Oversee proper collection of data and participate in the development and maintenance of computerized data collection system
    • Understand all relevant data standard including FDA Safety & Innovation Act of 2012 (FDASIA), CDISC / CDASH compliant data standards
    • Ensure conformance with GCP
    • Lead subordinates by developing, communicating, and building consensus for goals and programs that support division and company objectives
    • Assist with development of Monitoring Plan
    • Lead EDC development
    • Assist in development and implementation of strategy for data cleaning and in the design of clinical databasesGenerate data retrieval and complete reports as required
    • Familiarity with Clinical Data Management industry standards (i.e. CDASH, etc.)
    • Adheres to current Good Clinical Data Management Practices Guidelines (GCDMP)
    • Assist with the training of CRAs, Consultants, and Contract CRAs



    • Must have relevant experience developing and maintenance of clinical data management programs and databases
    • Minimum 5 years in relevant work
    • BS degree in related area
    • Prior people management and clinical data management experience required




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