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- Tasks: Lead quality assurance in clinical trials and ensure compliance with industry standards.
- Company: Join ICON plc, a leader in healthcare intelligence and clinical research.
- Benefits: Enjoy competitive salary, health insurance, flexible benefits, and work-life balance.
- Other info: Inclusive culture with opportunities for growth and development.
- Why this job: Make a real impact on innovative treatments while developing your leadership skills.
- Qualifications: Bachelor's degree in a relevant field and experience in clinical quality assurance.
The predicted salary is between 55000 - 65000 £ per year.
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 Compliance Lead at ICON, you will design and analyse clinical trials, interpreting complex medical data, and contribute to the advancement of innovative treatments and therapies.
What You Will Do:
- You will oversee quality assurance and compliance workstreams, ensuring deliverables meet quality and timeline expectations.
- Develop and implement comprehensive quality management systems and processes to ensure compliance with regulatory requirements, industry standards, and company policies.
- Lead internal and external audits and inspections, including planning, execution, and follow-up activities to address findings and ensure timely resolution.
- Conduct regular quality reviews of clinical trial documentation, protocols, and study reports, identifying areas for improvement and implementing corrective actions as necessary.
- Provide leadership and guidance to the clinical quality compliance team, including training, mentoring, and performance management.
- Collaborate with cross-functional teams to assess quality risks, develop risk mitigation strategies, and drive continuous improvement initiatives.
Your Profile:
You will have solid quality assurance and compliance experience, with the ability to manage competing priorities and develop your team.
Required qualifications and experience:
- Bachelor's degree or higher in a relevant scientific discipline or healthcare-related field.
- Previous experience in clinical quality assurance or compliance within the pharmaceutical, biotechnology, or CRO industry.
- Expert knowledge of regulatory requirements, including FDA/EMA regulations, ICH-GCP guidelines, and ISO standards.
- Strong leadership and project management skills, with the ability to effectively prioritize tasks and manage resources to meet objectives.
- Excellent communication, interpersonal, and problem-solving skills, with the ability to influence and collaborate with stakeholders at all levels of the organization.
- Willingness to travel to site as required about once per month.
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.
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.
Clinical Quality Compliance Lead employer: IRE
Contact Detail:
IRE Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Clinical Quality Compliance Lead
✨Tip Number 1
Network like a pro! Reach out to your connections in the healthcare and clinical research fields. Attend industry events or webinars, and don’t be shy about introducing yourself. You never know who might have the inside scoop on job openings at ICON!
✨Tip Number 2
Prepare for interviews by diving deep into ICON’s mission and values. Familiarise yourself with their recent projects and innovations. This way, you can show how your experience aligns with their goals and demonstrate your passion for shaping the future of clinical development.
✨Tip Number 3
Practice makes perfect! Conduct mock interviews with friends or mentors to refine your answers. Focus on articulating your quality assurance and compliance experience clearly, especially how it relates to regulatory requirements and industry standards.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, keep an eye on our careers page for new opportunities that match your skills and interests. We’re excited to see what you bring to the table!
We think you need these skills to ace Clinical Quality Compliance Lead
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Clinical Quality Compliance Lead role. Highlight your relevant experience in quality assurance and compliance, and don’t forget to mention any specific regulatory knowledge you have. We want to see how your background aligns with what we’re looking for!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about clinical quality compliance and how your skills can contribute to our mission at ICON. Keep it concise but impactful – we love a good story!
Showcase Your Leadership Skills: Since this role involves leading a team, make sure to highlight your leadership experience. Share examples of how you've mentored others or managed projects successfully. We’re keen to see how you can inspire and guide our clinical quality compliance team!
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way to ensure your application gets into the right hands. Plus, you’ll find all the details about the role and our company culture there. Don’t miss out on this opportunity!
How to prepare for a job interview at IRE
✨Know Your Regulations
Familiarise yourself with FDA/EMA regulations, ICH-GCP guidelines, and ISO standards. Being able to discuss these in detail will show your expertise and commitment to compliance, which is crucial for the Clinical Quality Compliance Lead role.
✨Showcase Your Leadership Skills
Prepare examples of how you've led teams or projects in the past. Highlight your experience in mentoring and performance management, as this will demonstrate your ability to guide the clinical quality compliance team effectively.
✨Be Ready for Scenario Questions
Expect questions that assess your problem-solving skills and ability to manage competing priorities. Think of specific situations where you identified quality risks and implemented corrective actions, as this will illustrate your proactive approach.
✨Collaborate and Communicate
Emphasise your communication and interpersonal skills during the interview. Be prepared to discuss how you've collaborated with cross-functional teams to drive continuous improvement initiatives, as this is key to succeeding in the role.