Mégane Regina

Clinical sites' main point of contact, accountable for quality and delivery of sites from Initiation to Close out of the trial. Oversees the conduct of the trial at designated sites ensuring the rights and well-being of human subjects are protected, quality and integrity of the reported data and the conduct of the trial is in compliance with the currently approved protocol/amendment(s), with GCP and with the applicable regulatory requirement(s).

Responsibilities include identification, selection, initiation, and close-out of appropriate investigational sites for clinical studies. Monitor those sites in order to ensure that studies are carried out according to the study protocol, ICON SOPs/WPs, applicable regulations and the principles of ICH-GCP Involvement, when required, in other areas of study management and staff training. Contribute to the review of ICON systems and procedures, as appropriate. Coaching and mentoring of monitoring competence to inexperienced/less experienced colleagues. Contribute to the culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs. Recognize, exemplify and adhere to ICON's values which center around a commitment to People, Clients and Performance. Independently and proactively coordinate the necessary activities required to set up and monitor a study.

Responsibilities include identification, selection, initiation, and close-out of appropriate investigational sites for clinical studies. Monitor those sites to ensure that studies are carried out according to the study protocol, company SOPs/WPs, applicable regulations and the principles of ICH-GCP Involvement, when required, in other areas of study management and staff training. Contribute to the review of company procedures as appropriate. Managed stock products and laboratory material