Clinical Quality Compliance Lead

Pharmaceutical Research Associates, Inc; United Kingdom; Remote; GBP 40,000 - 80,000

Job description

Overview
As a Clinical Quality Compliance Lead you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

Responsibilities

What you will be doing:

1. Under the leadership of the Operations Quality Lead, develop, contribute, and support facilitation, presentation, and communication of GCP Lessons Learned, GCP Cases, or other trending analysis.
2. Provide training or awareness for new or established processes or guidance.
3. In collaboration with the Operations Quality Lead and the Operations Quality Manager, provide consultation and support for ad hoc requests.
4. Stay current with knowledge of clinical trial requirements, ICH GCP guidelines, and global regulatory requirements for the management of clinical trials.
5. Facilitate and support cross-functional stakeholder engagement to ensure adequate representation for consultation towards consensus.
6. Develop matrix relationships to involve process experts and conduct improvement activities.
7. Become thoroughly familiar with assigned compounds and protocols.
8. Support overall quality within assigned clinical trials and submissions.
9. For assigned clinical trials or assets, is point of contact for operational related quality consultation, escalating to QA as needed.
10. Provide risk-management, consultation, assessment, and recommendations for escalation for potential quality issues or trends.

Qualifications

You are:

1. Bachelor's degree or equivalent with a strong emphasis on science or quality management.
2. Minimum of 5 years' experience in a pharmaceutical, bio-pharmaceutical, or Contract Research Organization company, or equivalent.
3. Minimum of 3 years' experience in quality role.
4. Must have working knowledge of ICH GCP and other relevant regulatory/health authority experience.
5. Working knowledge of Quality Management methods, systems, and relevant procedures.
6. Experience in providing quality management within Study Teams in the conduct and management of large and complex multinational clinical trials.
7. Experience in managing complex and sensitive operational challenges.
8. Experience in risk and issue management and in assessment of non-compliance against relevant study documents, procedures, ICH GCP, and regulatory requirements.

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:

1. Various annual leave entitlements.
2. A range of health insurance offerings to suit you and your family's needs.
3. Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead.
4. 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.
5. Life assurance.
6. Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.

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 organisation. 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.

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.

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