ICON plc

Clinical Data Science Lead

ICON plc

full-time

Posted on:

Origin:  • 🇺🇸 United States

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Job Level

Senior

About the role

  • Support the design, specifications, and development of eCRFs ensuring adherence to standards
  • Coordinate development and testing of clinical data management system edit checks and listings/reports/tools for data review and discrepancy management
  • Support development of Data Management Plan documents to ensure accurate, timely, consistent, high-quality clinical data
  • Work with Third Party/External data vendors to set up data import and reconciliation processes
  • Perform comprehensive review of all study data including Third Party/External data, SAE data and local lab data
  • Oversee quality control procedures and support filing of eTMF documentation to maintain inspection-ready environment
  • Develop and maintain communications and working relationships with CDM team and study stakeholders
  • Manage project timelines and quality with guidance from Principal Clinical Data Lead or Manager
  • Provide reports, status updates, feedback, and advice on data cleaning and risk identification/mitigation
  • Ensure CDM activities comply with GCP, ICH, SOPs, Job Aids, regulatory guidelines, and study specific plans
  • Support and assist subordinate staff and provide backup support for Principal

Requirements

  • 4+ years of Clinical Data Management experience
  • Ability to work under pressure demonstrating agility through effective and innovative team leadership
  • Robust experience with EDC (e.g. Medidata Rave)
  • Experience with Data Review tools such as elluminate, J-Review or Business Objects
  • Deep understanding of drug development and biopharmaceutical industry
  • Strong technical skills, including Microsoft Excel functionality
  • Fluent English (oral and written)
  • High attention to detail and proven ability to manage multiple, competing priorities
  • Excellent written and oral communication skills
  • Bachelor’s degree preferred (Statistics, Mathematics, Economics, Computer Science, IT, Biology, Social Science, etc.)