Central Monitor - Europe - Remote
Multiple Locations: Serbia • Bulgaria • Croatia • Romania
Requisition Number: 3943
Position Title: Central Monitor
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 2,500 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 are planned and executed in alignment with it and in adherence to ICH-GCP, SOPs, corporate standards and regulatory requirements.
- Perform 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.
- As required, develops and delivers training to the study team regarding the centralized monitoring strategy.
- Can provide subject matter expertise for the delivery of the centralized monitoring strategy required for the trial. Ensures the documentation of the centralized monitoring strategy in the appropriate functional plan and/or development of the central monitoring plan.
What you will bring to the role
- Knowledge of clinical project financial principles
- Ability to apply problem solving techniques to resolve complex issues and apply a risk management approach to identify and mitigate potential threats to the successful conduct of a clinical research project.
- Critical thinking and analytical skills to understand/ analyze complex data and provide insight into risk reports, trends and outliers in data
- Computer literate and numerate with a willingness to adapt to various computer systems.
- BSc/RN or equivalent combination of knowledge, skills and experience
- At least 8 years’ experience in clinical research required
- Prior experience 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. Demonstrated capability of working in global environment
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!
Employment Type: Regular
Community / Marketing Title: Central Monitor - Europe - Remote
We’re a global, mid-size CRO that pushes boundaries, innovates and invents — because the path to a cure for the world’s most persist diseases is not paved by those who play it safe, but by those who take pioneering, creative approaches, and implement them with quality and excellence. We are experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs, in the best possible way.
Location_formattedLocationLong: Bucharest, RO