Quality Assurance Auditor (Laboratory Vendors)

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 as a Supplier Performance Management Monitor.

What you will be doing:

• Monitoring the collection, processing, and analysis of data for sponsored clinical trials
• Monitoring and evaluating Supplier compliance and data quality
• Tracking corrective actions in relation to monitoring issues and audit findings; escalates as appropriate
• Developing professional relationships with client and vendor stakeholders
• Support the planning, management and execution of Supplier Performance Management Services related monitoring activities
• Support Global Development Operations, Global Study Management, and therapeutic area teams by monitoring to ensure the quality and integrity of processes and data generated by external Vendor/Service Supplier
• Gather business requirements to develop Pre-Visit letters and design and generate reports in support of supplier monitoring activities (eg, Clin Ops DB, IMS)
• Plan and conduct monitoring visits as delineated in the annual monitoring plan
• Assist in “in-house monitoring” or “remote monitoring” activities as delegated by management or business need
• Ensure the quality and integrity of processes and data generated by Suppliers for sponsor clinical trials
• Assist in the distribution and archival of key outputs from Supplier Performance Management Monitoring. (e.g. Monitoring Visit Reports)
• Support key governance forums (e.g. primary FMTs, charter immersion meetings) and ensure accurate records of oversight
• Oversee workspaces and/or repositories for team collaboration on documents and communication of timelines
• Support supplier management in overseeing monitoring activities through timely development and maintenance of business tools
• Identify and implement new business tools to enhance quality of Supplier Performance Management processes and report information
• Support special projects as identified by management or business need
• Facilitate execution of supplier surveys and address pertinent business issues
• Drive continuous improvement of Supplier Performance Management
• Communicate with internal and external business partners to identify opportunities for enhancing business operations

You are:

• Doctorate/ Masters/BA/BS/RN/AD/GED
• If Master’s degree, 3 years of directly related experience; if Bachelor’s degree, 5 years of directly related experience; if Associate’s degree, 10 years of directly related experience; if GED, 12 years of directly related experience
• Experience evaluating performance for clinical trial vendors 
  
  • laboratory vendors (required)
• GCP and GLP experience required 
• Technologist or work experience in laboratory technology and their application to clinical trials (preferred)

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 maximise savings and plan with confidence for the years ahead
• Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised 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, subsidised travel passes, health assessments, among others 

Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits 

At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we’ve done to become a more inclusive organization. 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 through this this form.