Teams at Novotech

Independently manage and monitor assigned clinical trial sites (based QLD/NSW/VIC), ensure participant safety and data integrity, perform SSU including SIVs, drive site performance and recruitment, liaise with investigators, sponsors and internal teams, and apply ICH-GCP to deliver Phase I-III studies.

Plans, prepares, reviews, and submits country- and site-level ethics and regulatory authority applications for clinical trial start-up, maintenance, and close-out. Ensures submission packages comply with ICH-GCP, local regulations, SOPs, and project timelines. Coordinates with regulatory start-up managers, project managers, investigative sites, ethics committees, IRBs, and regulatory authorities; tracks submissions and approvals; addresses review comments; and mentors junior staff.

Conducts clinical trial site monitoring to protect participants, verify source data, and ensure compliance with ICH GCP, regulations, and SOPs. Builds relationships with investigators and site personnel, supports regulatory and ethics submissions, drives participant recruitment, prepares site documents and plans, and performs site selection, initiation, monitoring, close-out, pharmacy, and co-monitoring visits onsite or remotely.