Independently manage all aspects of monitoring for assigned clinical trials across study phases, including site initiation, routine monitoring, and close-out visits.
Ensure compliance with protocols, GCP, ICH, SOPs, and applicable regulatory requirements.
Build strong site relationships, acting as a primary point of contact and ensuring high-quality data collection.
Identify and resolve site issues, escalating as needed to maintain trial integrity and patient safety.
Activities around regulatory affairs, site activation and study-startup.
Travel throughout The UK.
Requirements
Experience leading monitoring activities in complex trials, ideally in oncology or rare disease with a minimum of at least 5 years’ experience.
Strong understanding of ICH-GCP and regulatory guidelines.
Clear and confident communicator in English.
Comfortable working independently and managing priorities.