Job Duties:

• Develops strong site relationships and ensures continuity of site relationships through all phases of the trial.
• Performs clinical study site management/ monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents.
• Gains an in-depth understanding of the study protocol and related procedures.
• Coordinates & manages various tasks in collaboration with other sponsor roles to achieve Site readiness
• Works with site and local team to prepare and submit for Ethic Committee approval
• Collaborate with site and local team on study agreement negotiation and finalization
• Performs remote and on-site monitoring & oversight activities using various tools to ensure:

        -   Data generated at site are complete, accurate and unbiased

        -   Subjects’ right, safety and well-being are protected

• Conducts site visits including but not limited to validation visits, initiation visits, monitoring visits, close-out visits and records clear, comprehensive and accurate visit & non-visit contact reports appropriately in a timely manner.
• Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out.
• Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/ inspections and overall site performance.
• Identifies, assesses and resolves site performance, quality or compliance problems and escalates per defined Escalation Pathway as appropriate
• Manages and maintains information and documentation in systems as appropriate and per timelines.
• Support and/or leads audit/ inspection activities as needed
• Any adhoc projects under medical affairs department