Configuration & 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 is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

ICON plc is a world-leading healthcare intelligence and clinical research organization. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organizations.

With our patients at the center of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.

Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

The Role

• The Configuration/QC Specialist will be supporting 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.

What You Will Need

• University degree in medicine, science, or e quivalent
• Previous 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

What ICON Can Offer You

Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our Benefits Examples Include

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs.
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being.
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.

Visit our careers site to read more about the benefits ICON offers.

At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON 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 or submit a request here