Clinical Quality Management Lead

Overview

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

Responsibilities

What you will be doing:

• Lead teams for each new study to identify factors (processes and data) that are critical to quality and to proactively identify, prioritize, and manage important risks to quality.
• Ensure that operational feasibility and patient engagement insights are integrated into QbD/quality risk management activities and the associated clinical study protocol.
• Lead teams to identify study level quality tolerance limits (QTLs), set proper thresholds, and consistently oversee and manage performance.
• Perform oversight to ensure that quality risk management plans are promptly implemented and routinely updated, specifically in response to protocol amendments, quality issues, and audit/inspection findings.
• Design and implement methods to drive portfolio/program level quality risk management.
• As the subject matter expert for risk-based monitoring/study management, support study teams to decide the best strategy/approach for monitoring (considering effectiveness and efficiency), ensuring it is consistently focused on critical to quality factors (data and processes) in relation to level of risk
• Support and oversee study teams to ensure that inspection readiness tools are consistently and appropriately maintained
• Lead execution and oversight of business process management for 'Perform Clinical Drug Development' ensuring appropriate definition, elaboration, integration, documentation, measurement, and continuous improvement for associated processes.
• Ensure process metric dashboards are created and routinely used to facilitate process oversight.
• Support/consult with colleagues and teams to provide first level guidance on qualityrelated issues and processes

Qualifications

You are:

• Bachelor's or Master's degree in Medical or Life Science (or equivalent industry experience)
• Expert knowledge of and experience in (minimum of 8 years) processes related to clinical trial design, planning, start up, conduct, analysis, and reporting clinical development (principles and concepts as well as regulatory environment).
• Strong understanding of Quality by Design principles, clinical quality riskmanagement processes, risk-based monitoring, and trial oversight
• Record of successful vendor interactions. Strong knowledge management, project management and change management skills.
• Strong data insights and analytical skills to identify trends and drive quality/process improvements.
• Ability to make risk-based decisions based on a robust benefit/risk assessment.
• Ability to lead GCP inspection readiness activities and support global health authority inspections.
• Acts as GCP/risk-based quality management Subject Matter Expert for clinical activities

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: 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, 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 through the form below. 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.