ICON Clinical Research CDA (Risk Management Expert) - Office based only at multiple locations. in Czech Republic
As a Clinical Data Analyst you will work as part of a global team, contributing to the implementation of risk based monitoring. This role will allow you to gain new skills and invaluable knowledge of Clinical Risk Management which will be of benefit in your longer career.
Role & Responsability:
As Clinical Risk Management functional lead, the CDA is responsible for guide project teams through set-up and implementation of risk based monitoring strategy for one or more studies. Additional responsibilities will include:
Create the Central Monitoring Plan
Support set-up and testing of data analysis tools
Review clinical and operational study data to identify potential site performance and site organization issues
Train and support the project teams for the use of Clinical Risk Management systems and processes
Manage operational risk log for Clinical Risk management activities
Communicate effectively with the project team, CRAs, Project Managers, Clinical Trial Managers, DM Staff, Medical staff, Scientific Council to ensure decisions are taken to support adequate monitoring intervention and effective resolution of site performance issues
Work with Data Management, Clinical Operations, Central Laboratory, ITG, Biostatistics, Medical Writing, Regulatory Affairs and Quality Assurance to ensure all data collected within a clinical study are managed according to corporate standards and meet regulatory guidelines for data integrity.
Experience & Qualifications:
The ideal candidate will have significant clinical research associate (CRA) or clinical data management experience and Risk Based Management.
Bachelor’s degree or local equivalent in a scientific discipline and/or appropriate experience
Site monitoring experience
Experience in Risk Based Monitoring
Knowledge of regulatory requirements respecting data quality and clinical trials conduct.
Must possess excellent oral communication skills and attentiveness to detail.
Proven leadership skills and the ability to work independently to resolve study related issues
Knowledge of database technologies and processes.
Excellent interpersonal skills required
- What’s Next?*
Following your application if you are successful you will be invited to an initial telephone interview with one of our dedicated recruiters who will be able to provide you with more details of this opportunity
- ICON is an equal opportunity employer - Minorities/Females/Disabled/Veterans and committed to providing a workplace free of any discrimination or harassment*