Teams at Novotech

Manages clinical research projects from site selection through study closeout, overseeing timelines, budgets, risks, vendors, sites, recruitment, regulatory submissions, data management, safety activities, and essential documentation. Serves as the primary client contact, leads internal teams, ensures compliance with ICH GCP and applicable regulations, manages project profitability, supports feasibility and business development activities, and contributes to process improvement.

Conduct independent site monitoring for biotech and pharmaceutical clinical trials across Phase I–III studies. Build partnerships with investigators and site teams, support patient recruitment and site performance, collaborate with sponsors and internal teams, and ensure participant safety, regulatory compliance, and clinical data quality. CRA II applicants need at least six months of independent monitoring experience; CRA III applicants need at least two years.

Lead end-to-end clinical trial delivery including planning, site selection, vendor management, team leadership, budget and revenue management, risk mitigation, regulatory and ICH GCP compliance, eTMF/CTMS oversight, recruitment monitoring, client liaison, and audit/inspection readiness.