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ICON plc

Clinical Quality Project Manager

Posted 4 Days Ago
Be an Early Applicant
In-Office or Remote
Hiring Remotely in Dublin, IRL
Senior level
In-Office or Remote
Hiring Remotely in Dublin, IRL
Senior level
The Senior GCP QA Manager leads cross-functional teams to manage Quality Events by conducting RCA and CAPA, ensuring compliance, and liaising with clinical functions and external parties to uphold quality standards.
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Senior GCP QA Manager

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 Clinical Quality Project Manager you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

The role is 100% embedded within a company that creates transformative medicines for people with serious diseases with a focus on specialty markets.

You will play a key role in making improvements to how teams perform their work, supporting positive gains on compliance and reducing procedural complexity within the Clinical Quality Assurance team.

What You Will Be Doing:

  • Support inspection readiness and inspection preparation activities for Global Clinical Operations, including SME training/preparation and back-room activities, and support back room during GCP inspections, as needed.

  • Support and/ or facilitate Inspection Readiness Milestone Reviews for assigned studies at First Subject First Visit (FSFV), Last Subject Last Visit (LSLV) and Database Lock (DBL) milestones.

  • Support Inspection lessons learned activities.

  • Contribute to the development of responses to GCO inspection findings to ensure findings are appropriately addressed

Your Profile:

  • Requires 5 years of relevant work experience, or the equivalent combination of education and experience 

  • Strong verbal/written communication, presentation skills and interpersonal skills to educate/train project teams and other stakeholders and exchange key information. 

  • Effectively communicates and coordinates activities with TMF stakeholders both inside and outside the group 

  • MS Excel, Word, PowerPoint expertise 

  • Experience working in a TMF platform. 

  • Experience working in a CTMS platform 

  • Excellent attention to detail 

#LI-Remote

#LI-RS1

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, 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 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.

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.

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

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ICON plc Dublin, Dublin, IRL Office

ICON plc, South County Business Park, Dublin, Ireland

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