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Senior CDC

JR071827

About the role

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At ICON, it's our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients' lives.Our 'Own It' culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organisation that delivers excellence to our clients and to patients at every touch-point. In short, to be the partner of choice in drug development.That's our vision. We're driven by it. And we need talented people who share it.If you're as driven as we are, join us. You'll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you'll be helping shape an industry.

We have an incredible opportunity for a Senior Clinical Data Coordinator to join the team.

LOCATION OPTIONS

  • United States (home-based OR office-based)
  • Mexico (office-based with some remote flexibility)

    Summary:

    In accordance with project specific timelines, to perform data management activities to ensure the generation of accurate, complete, and consistent clinical databases. To assist with the training of less experienced Clinical Data Coordinators. To fulfill job responsibilities in accordance with Good Clinical Practices (GCPs}, ICON Standard Operating Procedures (SOPs}, Working Procedures (WPs}, Study Specific Procedures (SSPs), International Committee on Harmonization (ICH) Guidelines, and all applicable law and regulations.

    Highlights of Key Responsibilities:

  • Review CRF I eCRF data for completeness, accuracy, and consistency via computerize edits and manual data checks.
  • Perform external data reconciliation
  • Perform Serious Adverse Event reconciliation
  • Generate and close/resolve (as appropriate) data queries
  • Freeze and/or lock eCRFs (as appropriate) within the Electronic Data Capture System
  • Create and maintain study files and other appropriate study documentation
  • Perform User Acceptance Testing (UAT) and collaboratively work with CDMS personnel to see issues found through re-testing and resolution
  • Assist Data Management Study Lead in development of eCRF, Data Validation Specifications, and Study Specific Procedures
  • Train and guide less experienced CDCs in data management requirements and activities.

    Requirements:

  • 2+ years of clinical data management experience
  • Excellent written and oral communication skills
  • Excellent accuracy and attentiveness to detail
  • Capability to work within a team environment.
  • Knowledge of database technologies and processes
  • Knowledge of regulatory guidelines in relation to data quality and clinical trials conduct
  • Bachelors degree in a scientific discipline

    Benefits of Working in ICONOur success depends on the quality of our people. That's why we've made it a priority to build a culture that rewards high performance and nurtures talent.We offer very competitive salary packages. And to keep them competitive, we regularly benchmark them against our competitors. Our annual bonuses reflect delivery of performance goals - both ours and yours.We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans - and related benefits such as life assurance - so you can save and plan with confidence for the years ahead.But beyond the competitive salaries and comprehensive benefits, you'll benefit from an environment where you are encouraged to fulfil your sense of purpose and drive lasting change.ICON is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

    If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.

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