At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives.
Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organisation that delivers excellence to our clients and to patients at every touch-point. In short, to be the partner of choice in drug development.
That’s our vision. We’re driven by it. And we need talented people who share it.
If you’re as driven as we are, join us. You’ll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you’ll be helping shape an industry.
Overview of the Role:
The Senior Project Analyst (Risk-Based Quality Management) will be responsible for supporting the activities of RBQM (Risk-Based Quality Management) within the ICON Biotech division, across a wide variety of therapeutic areas, clients and projects. They are responsible for supporting activities to ensure that robust and high-quality initial study risk assessment and, ongoing risk management occurs on every study, in accordance with required timelines and with SOPs and ICH-GCP guidelines.
Responsibilities include:
Ensure robust and high-quality initial study risk assessment and, ongoing risk management occurs on every study, in accordance with required timelines and with SOPs and ICH-GCP guidelines
Oversee risk management tool completion and updates throughout study, e.g. to ensure critical data and process identification, risk initial input occurs, and overall quality is achieved with risk and mitigation identification.
Ensures risk-based monitoring strategies are included in all applicable functional plans, and ensures strategies are correctly configured in technology solutions
Supports RBQM Quality Gate assessments during study start up, and during study change implementation
Production of risk management metrics (e.g., compliance, mitigation effectiveness, deviation management)
Analyze, summarize & report on Risk Management; trend analysis to inform future knowledge library
Ensure agreement on QTLs (parameters and thresholds) achieved
To be successful, you will need:
Good working knowledge of ICH E6 and E8.
A keen interest in Risk-Based Quality Management, Centralized Monitoring and Quality Oversight and Governance.
Excellent communication skills
Timeline management experience
Good critical analysis skills
Minimum Education qualification is Bachelor's or Master's Degree in any Life Science field
Experience required: 3-6 years
This is home based job
Benefits of Working in ICON:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a culture that rewards high performance and nurtures talent.
We offer very competitive salary packages. And to keep them competitive, we regularly benchmark them against our competitors.
We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans – and related benefits such as life assurance – so you can save and plan with confidence for the years ahead.
But beyond the competitive salaries and comprehensive benefits, you’ll benefit from an environment where you are encouraged to fulfil your sense of purpose and drive lasting change.
ICON is an equal opportunity and inclusive employer and 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 through the form below.
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