Clinical Quality Management (CQM) Associate - Home-Based

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.

The Clinical Quality Management Associate is a detail oriented profession, who supports the CQM department in areas of process, training and compliance, SUSAR distribution, and ensuring that studies are inspection ready.

• Distributes SUSAR reports to investigators
• Runs and distributes compliance reports
• Assists in vendor oversight
• Performs QC of documents and participates in revisions
• Routes documentation for appropriate signage
• Collects, organizes and prepares regulatory documentation for transfer to Trial Master File and assists with tracking of document under guidance
• Helps to develop and maintain tracking tools for event investigation, training, SUSAR distribution and inspection readiness
• Coordinates meetings, prepares agendas and takes minutes
• Supports internal training initiatives for new hires and ongoing training for study teams.
• Provides Administrative training support to users with curriculum and user group creation, training items and user assignment.
• Responsible for ongoing maintenance of the GCO component of learning portals 
• Manages the collection and retention of training signature logs
• Coordinates tracking of external training activities
• Produces metric reports for event investigations
• Performs other duties as assigned.  

• B.S. or Advanced Degree (or equivalent degree/experience in the opinion of the Hiring Manager)
• Minimum of 1-4 years of relevant work experience
• Strong communication (written and verbal) skills to be able to interact with internal groups as well as external groups
• Strong attention to detail
• Demonstrates a working knowledge of ICH GCP regulations and clinical protocols
• Exhibits ability to ‘multi-task’ effectively
• Ability to interact well with various team members and provide value added support to project
• Displays ability to independently solve routine problems following standard policies/procedures

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

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, 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.

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.