Who we are
We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence.
We are Worldwide Clinical Trials, and we are a global team of almost 3000 experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs – in the best possible way.
Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit.
What you will do
- Understands the assigned protocol and ensures central monitoring activities planned and executed in alignment with it and in adherence to ICH-GCP, SOPs, corporate standards and regulatory requirements.
- Has knowledge of the study budget and understands their assigned tasks. Performs central monitoring activities including review of system outputs, identification of outliers, trends or signals and propose actions for assessment by study team. Follow-up with study teams as appropriate for action or issue resolution.
- Ensures the documentation of the centralized monitoring strategy in the appropriate functional plan and/or assists with development of the central monitoring plan.
- Completes User Acceptance Testing (UAT) of RBQM technology. Conducts and documents study/site level review of Key Risk Indications/Key Performance Indicators and where required and tracking of study Quality Tolerance Limits (QTLs)
What you will bring to the role
- Excellent communication, presentation and interpersonal skills.
- Excellent planning and organizational skills with effective time management
- Critical thinking and analytical skills to understand/ analyses complex data and provide insight into risk reports, trends and outliers in data
Your background
- BSc/RN or equivalent combination of knowledge, skills and experience
- At least 1 years' experience in clinical research required
- Knowledge and good understanding of Central Monitoring and associated ICH/Regulatory guidance required
- Demonstrates critical thinking skills to determine the cause and appropriate solution in the identification of issues.
Why Worldwide
At Worldwide, we balance fun with the serious business of changing lives. We have a values-driven culture that is built from the ground up. We empower our team members to treat every clinical trial like a patient’s life depends on it – because it does. Our leaders are in the trenches with you - committed to advancing science and moving mountains for our customers.
Interested in hearing more about Worldwide or our roles? Check out our careers page at www.worldwide.com/careers!
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