Clinical Systems Config & QC Specialist I

ICON San Antonio; Dublin; On-site; EUR 45,000 - 65,000; Full time

Benefits offered by this job

Health insurance

Annual leave entitlements

Retirement planning

Employee assistance program

Life assurance

Flexible country-specific benefits

Job summary

ICON plc in Ireland seeks a Configuration/QC Specialist to support the Project Management Team in configuring and QC’ing new clinical studies across ILS systems in line with CLW specifications. You will prepare site documents, coordinate packaging and shipping, and update Lab Manuals and Requisition Templates as needed.

In this role you will perform quality checks on databases and forms, and provide guidance to Project Managers on study configuration tasks while ensuring clear, accurate

Qualifications

• University degree in medicine, science, or equivalent.
• Monitoring experience in medium sized studies, including study start-up and close-out.
• Knowledge of ICH-GCP guidelines and ability to review and evaluate medical data.
• Excellent written and verbal communication.
• Ability to work to tight deadlines.

Responsibilities

• The Configuration/QC Specialist will support the Project Management Team (PM) in configuring and QC’ing new clinical studies in all ILS systems according to the specifications of the Client Laboratory Worksheet (CLW).
• You will create supporting documents for the site to facilitate proper specimen collection, coordinate packaging and shipping including visit requisitions, reference range tables, and study specific Lab Manuals and collection guides.
• Ensure information is clear and accurate and seek guidance on any parameters that need clarification. When updates or updates are requested the Configuration/QC Specialist will work with Leadership to determine whether those updates are warranted in the Lab Manual or Requisition Template and make those updates accordingly.
• The Configuration/QC Specialist will perform new study configuration quality checks on all databases, internal forms and supporting documents to ensure high quality output and adherence to the CLW specs and provide technical support and guidance to Project Managers for all study configuration tasks.

Skills

ICH-GCP guidelines knowledge

Excellent written and verbal comms

Ability to work to tight deadlines

Education

University degree in medicine, science, or equivalent

Job description

ICON plc in Ireland seeks a Configuration/QC Specialist to support the Project Management Team in configuring and QC’ing new clinical studies across ILS systems in line with CLW specifications. You will prepare site documents, coordinate packaging and shipping, and update Lab Manuals and Requisition Templates as needed.

In this role you will perform quality checks on databases and forms, and provide guidance to Project Managers on study configuration tasks while ensuring clear, accurate