1. Involvement in the site selection process.2. Collection of site documents for the Health Authority (HA)/Regulatory Authority (RA) submission and Ethics Committees (EC)/ Institutional Review Board (IRB)3. Planning of Site Visits, Report preparation as per visit, follow-up to the site- Site Selection, Site Initiation, Routine Monitoring (Remote / On-site) and Close Out Visits according to Study Manual, Protocol, Local Regulation, Good Clinical Practice (GCP) and SOPs.4. Follow up of trial progress and source data verification. Review of electronic Case Report Form (eCRF) completeness and query resolution by the sites. Escalate issue(s), when necessary.5. Recruitment Follow up on patient enrolment and patient status. Site facility & staff. Assure that site facilities are adequate, according to protocol needs, local regulations, GCP and applicable SOPs (global/local). Assure site staff training and access to different systems.6. Good understanding of the principles of ICH-GCP and applicable local regulatory requirements.