Clinical Trial Manager at ICON plc

What you will be doing:

• Has the overall responsibility for the study commitments within the country and for timely delivery of data to required quality.
• Leads Local Study Team consisting of CRA(s), CTA(s), for assigned study/studies
• Coordinates the site selection process by identifying potential sites/investigators, performing initial Site Quality Risk Assessment, and conducting Site Qualification Visits to evaluate suitability and quality risks.
• Ensures timely submission of application/documents to EC/IRB at start up and for the duration of the study.
• Works together with Regulatory Affairs to ensure timely delivery of application/documents for submissions to Regulatory Authority for the duration of the study, and in line with local regulations.
• Ensures all country and site level trial essential documents required by ICH-GCP prior to study start have been collected and verified for correctness, prior to setting sites ready to enroll, and in line with SOPs.
• Sets up and maintains the study in CTMS at study country level as well as local websites as required by local laws and regulations.
• Oversees, manages and coordinates monitoring activities from site activation through to study closure at country and site level in accordance with the Monitoring Plans.
• Reviews monitoring visit reports (as required and following SOPs) and pro-actively advices the monitor(s) on study related matters.
• Performs any required co-monitoring, Accompanied Site Visits/training visits with study CRAs.
• Participates in training and coaching new members of the Local Study Team ensuring compliance with ICH-GCP

You are:

• Bachelor degree in related discipline, preferably in life science, or equivalent qualification.
• Solid experience in Development Operations (CRA, SrCRA) or other related fields
• Excellent verbal and written communication skills.
• Ability to travel as required