Configuration & Quality Control Specialist 1

Configuration & Quality Control Specialist I, Hybrid Bulgaria

ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.

As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.

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 additions 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 equivalent
• 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

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Employment with ICON is contingent upon having the legal right to work in the country where the role is based.

Rewards & Benefits

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.

Benefits may include:

• Competitive base salary and performance related incentives
• Health and wellbeing programmes including medical, dental, and vision coverage where applicable
• Retirement and pension plans
• Life assurance and disability coverage
• Employee assistance programmes and wellbeing resources
• Learning and development opportunities through structured training and career pathways

Benefits may vary depending on role and location.

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

Inclusion and Accessibility

ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.

If you require reasonable accommodations during the recruitment process, please let us know or submit a request here.

Are you a current ICON Employee? Please click here to apply