Andreas Chronopoulos

Associate Regulatory & Start-up Manager @IQVIA

GB

Oversight of the planning, submissions and approval stage of protocol amendments during the maintenance phase of the study- Updating the Amendment Addendum in the Study Start-Up (SSU) Plan or create the Amendment Plan for those studies without a SSU plan- Oversight for the Ethics Submission approval processes (including, but not limited to timeline management, ensuring core documents are received timely- Maintain and manage SSU data tracking entries in relevant databases. Review for completeness and accuracy- Preparing and providing reports to study management as appropriate- Prepare and QC study start-up reports to assist SSUM with data reporting to internal teams and/or Sponsors. This could include infostart reports, SAPT reporting, reporting on country / site status- Reviewing and identifying project study trends and proactively responding to client and respective team members- Implement and manage a risk based approach to all activities, identifying potential obstacles to the successful completion of deliverables and developing innovative solutions to challenges- Ensure project level compliance with study specific training requirements outlined in the study training matrix- Responsible for assuring projects assigned are run according to SOPs and WP as defined in the scope of work- May act as back-up on currently allocated for SSUM during time out of office- Supports SSUM with directional insight for Change Orders and Out of Scope work- Responsible for supporting SSUMs thorough management of project timelines ensuring activities are completed by the timelines agreed- May assist the study management team with continuous planning of work completed versus ongoing requirements which will feed into the overall budget management of the study- Maintain compliance with IQVIA Biotech SOPs, CAPA completion and timesheet maintenance in accordance with IQVIA Biotech standards.

University of Bradford

Postgraduate Diploma

National & Kapodistrian University of Athens

Certificate

American College of Greece

BSc

Heriot-Watt University

MSc

Hellenic Open University

BSc (Hons)

Bradford University School of Management

Doctor of Philosophy (PhD)