Clinical Quality Compliance Specialist
hace 2 semanas
As a Clincial Quality Compliance Lead you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.**What you will be doing**:- 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- Provide training or awareness for new or established processes or guidance- In collaboration with the Operations Quality Lead and the Operations Quality Manager, provide consultation and support for ad hoc requests- Stay current with knowledge of clinical trial requirements, ICH GCP guidelines, and global regulatory requirements for the management of clinical trials- Facilitate and support cross-functional stakeholder engagement to ensure adequate representation for consultation towards consensus- Develop matrix relationships to involve process experts and conduct improvement activities- Become thoroughly familiar with assigned compounds and protocols- Support overall quality within assigned clinical trials and submissions- For assigned clinical trials or assets, is point of contact for operational related quality consultation, escalating to QA as needed- Provide risk-management, consultation, assessment, and recommendations for escalation for potential quality issues or trends.**You are**:- Bachelor’s degree or equivalent with a strong emphasis on science or quality management- Minimum of 5 years’ experience in a pharmaceutical, bio-pharmaceutical, or Contract Research Organization company, or equivalent- Minimum of 3 years’ experience in quality role- Must have working knowledge of ICH GCP and other relevant regulatory/health authority experience- Working knowledge of Quality Management methods, systems, and relevant procedures- Experience in providing quality management within Study Teams in the conduct and management of large and complex multinational clinical trials- Experience in managing complex and sensitive operational challenges- 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:- 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
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Specialist, Clinical Event Validation
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Clinical Systems Specialist
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Manager, Quality Compliance
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Clinical Data Quality Associate
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Clinical Study Team Assistant I
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Senior Clinical Trial Manager, Oncology
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Manager, Clinical Operations
hace 1 semana
Desde casa, México IQVIA A tiempo completo**Based in Mexico for Sponsor Dedicated** **Job Overview** Manage a team of clinical staff working in support of clinical studies for Sponsor Dedicated model, to ensure projects are appropriately resourced and employees are trained and meeting project objectives. **Essential Functions** - Manage staff in accordance with organization’s policies and...
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Manager, Clinical Operations
hace 1 semana
Desde casa, México IQVIA A tiempo completo**Based in Mexico for Sponsor Dedicated****Job Overview**Manage a team of clinical staff working in support of clinical studies for Sponsor Dedicated model, to ensure projects are appropriately resourced and employees are trained and meeting project objectives.**Essential Functions**- Manage staff in accordance with organization’s policies and applicable...
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Clinical Operations Manager
hace 1 semana
Desde casa, México IQVIA A tiempo completoJob Overview Manage a team of clinical staff working in support of clinical studies to ensure projects are appropriately resourced and employees are trained and meeting project objectives. Essential Functions - Manage staff in accordance with organization’s policies and applicable regulations. Responsibilities include planning, assigning, and directing...
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Desde casa, México IQVIA A tiempo completoprojects are appropriately resourced and employees are trained and meeting project objectives.Essential Functions- Manage staff in accordance with organization’s policies and applicable regulations. Responsibilities include planning, assigning, and directing work, assessing performance and guiding professional development, rewarding and disciplining...
