Teams at Novotech

Lead and manage clinical trial projects end-to-end, ensuring compliance with ICH GCP and local regulations. Oversee budgets, timelines, vendors, site selection and activation, recruitment, eTMF/CTMS maintenance, safety and data coordination, and client communications to deliver projects on time and on budget.

Support start-up phase of clinical trials by preparing, submitting, and tracking country- and site-level ethics and regulatory authority applications per ICH-GCP and local requirements. Act as contact for sites, manage submission timelines, respond to reviewer queries, and advise project leads on local regulations to enable timely approvals.

Manage site relationships and monitor clinical trials to ensure participant safety and accurate data. Perform site initiation, monitoring, and close-out visits (onsite or remote), support regulatory and ethics submissions, prepare essential documents, drive site recruitment, and ensure compliance with ICH GCP, local regulations, and Sponsor/Novotech SOPs.