• Act as the main line of communication between the project team, sponsor, and the site • Build and maintain a good relationship with the site staff involved in the study conduct • Prepare, conduct, and report site selection, initiation, routine monitoring and close-out visits • Ensure that subject recruitment targets are timely defined, communicated, recorded and met, and project timelines are followed at site level • Ensure accurate and timely information flow with trial sites on Adverse Events and protocol/process deviations • Perform source data verification and follows up on data queries at site level; review and manage study risks on a site level • Ensure proper handling, use, accountability, reconciliation, and return of all Investigational Product(s) and clinical study supplies on sites • Review essential study documents and reconcile study Investigator Site File (ISF) / TMF at site level • Ensures quality (data integrity and compliance) at site level • Conduct site audit preparation visits and resolve site audit findings • Participate in study site audits and client onsite visits, as required • Ensure the flow of documents and study supplies between the project team, site and the Central/ Regional Laboratory/ Central Reviewer/ Warehouse • Conduct project-specific training of site investigators • Support preparation of Investigator newsletters • Assist Site Management Associates in maintaining study-specific and corporate tracking systems at site level • Support preparation of draft regulatory and ethics committee submission packages • Support collection of IP-RED packages at site/country level • Facilitate review and reconciliation of the study TMF on country and site levels