• Oversight of site level tasks associated with efficient site activation in accordance with ICH/GCP guidelines, local regulations, SOPs and project requirements • Identifying potential research sites that align with the study's criteria and assessing their capabilities and resources • Conduct initial site outreach, i.e., site engagement, collection of Confidentiality Agreement, and feasibility survey • Remote Pre-Study Visits and follow up documentation, including visit preparation, trip report completion, and other documentation as required • Support customization and translation of informed consent forms and patient-facing materials • Collect, track and perform a quality review of all essential documents required for effective and compliant study site activation • Maintenance and ongoing awareness of site regulatory compliance, supporting IRB/Independent Ethics Committee (IEC) annual renewals, PI change-over, and document expirations • Actively participate in team meetings to facilitate study progress and implement action plans for site level risks, underperforming sites, or issues impacting project milestones • Support the CRA team in preparing for site initiation visits (SIVs) • Responsible for submissions to and liaise with applicable IRB/IEC, Third Bodies, and Regulatory Authorities • Perform initial contract and budget negotiations with the sites • Ensure high quality documents are filed in applicable systems in accordance with SOPs and project requirements and that the Trial Master File (TMF) is updated and audit ready at all times • Track the progress of the start-up process and ensure that the research site meets all requirements and deadlines • Perform Case Report Form (CRF) review and data validation against source documentation according to protocol and guidelines as applicable in combination with monitoring for site protocol deviations.