Teams at Novotech

Manage end-to-end clinical research projects from feasibility and site selection through study closeout. Lead internal teams, vendors, budgets, timelines, risk mitigation, regulatory submissions, recruitment, site performance, documentation, data management, and pharmacovigilance activities while ensuring compliance with ICH GCP, regulations, SOPs, and client agreements.

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.