Clinical Data Quality Specialist

  • Celerion
  • Belfast, UK
  • 04/09/2020
Full time Data Science Data Analytics Big Data Data Management Statistics

Job Description

JOB DESCRIPTION

Every member of the Celerion team is involved in making something essential – a distinctive contribution to the health and well-being of people around the world. That’s the sense of purpose shared by employees throughout Celerion. We’re an early phase drug research company, operating in robust and growing markets. We have an exciting future and offer a strong development environment for our excellent employees.

We are looking for a Clinical Data Quality Specialist to join our clinic team in Belfast, N.Ireland.

This role is responsible for the review and verification of all clinical trial source data and will conduct data reconciliation and final checks before the data is sent to our Clinical Data Management team. You will ensure the completeness, accuracy and consistency of source data so that it meets the standards of quality expected for reporting to Sponsors and regulatory bodies. You will participate with multidisciplinary teams involved in setting up, conducting and reporting clinical trials.

Essential Functions:

For all assigned studies, ensure the following:

  • Ensure QC reviews are completed after the completion of the event real-time and in accordance with study specific
  • Ensure consistent and complete review of source data by completing all study specific QC review requirements
  • Meet with Clinical Data Managers and Clinical Study Managers to review any study specific source data forms prior to study start to ensure completion, accuracy, and ability to capture study information required to complete the study specific Case Report Forms and required by the study protocol and Celerion SOPs/PGs
  • Review source data on an ongoing basis to ensure the following:
    • Medical history and Informed Consent Form is complete according to GCP and regulatory guidelines and all subjects meet study eligibility according to the study protocol
    • Clinical source data is complete according to GCP and regulatory guidelines, protocol deviations (if applicable) are documented, and source data is collected in accordance with Sponsor requirements, and Celerion SOPs/PGs
    • All deviations and documentation errors are sent to clincial staff for correction and updates in real time in the same shift
    • Ensure data corrections are completed according to GCP guidelines, and Celerion SOPs/PGs
    • Complete a Final QC to ensure all source data is accounted for and has been QC reviewed
  • Monitor clinical conduct event completion to verify data collection meets ALCOAC standards
  • Oversee staff submission of completed source documentation during conduct shifts to verify accurate and complete data collection

An attractive salary and benefits package is available. Training will be provided on Celerion's data collection and quality procedures.

Celerion is an equal opportunity employer.

JOB REQUIREMENTS

Knowledge/Skills/Education/Licenses:

  • High School Diploma or GED/A Level required (relevant internal Celerion experience in lieu preferred)1-2 years industry experience preferred
  • Previous QC or related experience preferred
  • Excellent oral and written communication skills
  • Ability to organize and manage multiple priorities
  • Experience working in an environment with complex processes and defined criteria
  • Excellent time management
  • Proficient in MS Office applications required
  • Ability to work a flexible schedule, including days/evenings/weekends, to accommodate clinic activity