Central Monitor

Recognize, exemplify and adhere to ICON's values which center around our commitment to People, Clients and Performance. As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.

 *Conduct risk indicator analysis via review of data listing, study specific data sets and aggregated data, make independent and sound decisions on analysis results. This includes the review of several sources of operational, clinical and other type of data.

*Performs data entry of Clinical Data Analysis and Central Monitor analysis results for communication to the project team.

*Supports implementation of central monitoring activities as requested by 2016 ICH GCP guidelines paragraph 5.18.3, specifically by focusing on central monitoring of aggregated data.

Facilitates site oversight and early decision making by the Clinical trial Managers by identifying risks trends to critical study processes and data, as requested by ICH E6 guidelines paragraph 5.0.2. With the 2016 ICH GCP,

in Patient Centric Monitoring studies, support the Clinical Data Analyst with the set-up of the analysis platform, listing and Patient Centric Monitoring working tools for Clinical Data Analysts, Central Monitors and CRAs. With the 2016 ICH GCP and RBM guidance documents,

in the conduct of Patient Centric Monitoring studies, support the Clinical Data Analyst with the preparation of the Quality Risk Review Meetings and overall inspection readiness.

Attend project meetings where required. In studies not involving a Clinical Data Analyst, work independently for communication of central monitoring outputs and inspection readiness to the project team.

In Patient Centric Monitoring studies, support the Clinical Data Analyst with the preparation, conduct and follow-up of the Patient Centric Monitoring meetings with CRAs. Travel (approximately 5%) domestic and/or international. Other duties as assigned.