Clinical Data Analyst - Clinical Risk Management Functional Lead

Clinical Risk Management functional lead/ Clinical Data Analyst/ CDA  

ICON is a respected global CRO providing drug development solutions to the Pharmaceutical; Biotechnology and Medical Device industries.

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 & Responsibility:

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.
• ·         Bachelor’s degree or local equivalent in a scientific discipline and/or appropriate experience
• ·         Site monitoring experience
• ·         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
• Ability to work within a team environment and manage competing priorities in a changeable environment
• Knowledge of database technologies and processes.
• Ability to handle stressful situations and deadlines.
• 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