About the role
<p>Join Excelya, where Audacity, Care, and Energy define who we are and how we work. We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.</p><p>In this hands-on role, you will support site activation, documentation, regulatory submissions, and ensure TMF quality and inspection readiness. Working closely with cross-functional teams, you will help drive efficient study execution while maintaining full compliance with regulations and internal standards.</p><p></p><p><strong>Main Responsibilities:</strong></p><ul><li>Coordinate site activation activities and ensure all essential study documentation is collected, reviewed, and filed </li><li>Support the site “green-light” process prior to site initiation </li><li>Organize and prepare Site Initiation Visits (SIVs) and ensure ISF readiness </li><li>Act as a key contact for external monitors and manage system access </li><li>Track and support resolution of site and monitoring-related issues </li><li>Review monitoring reports and maintain oversight of study action items </li><li>Ensure timely follow-up and closure of site and monitor action points </li><li>Monitor site performance, identify risks, and prepare operational reports </li><li>Support regulatory submissions and manage distribution of study documentation </li><li>Perform TMF reviews, support audits, and contribute to quality and process improvement initiatives</li></ul>