• Collaborate with COL (Clinical Operations Lead) to set targets for clinical monitoring activities, and ensuring the recording of the trial in compliance with project goals • Conduct and oversee the clinical trial site feasibility and site selection process • Create, maintain and implement trial-specific plans, tools and documents required per SOP (Standard Operating Procedure) (e.g., training material, annotated trip reports, Clinical Monitoring Plan, Deviation Handling Plan) • Oversee or perform collection of clinical trial site specific documents ensuring on time regulatory submissions (CA, IRB/IEC) according to local requirements • Driving the clinical site initiation and greenlight process according to project goals • Actively contribute to clinical trial site management and engagement to establish and maintain close site relationships • Organize and oversee project-specific training for CRAs (Clinical Research Associate) and clinical trial sites • Review trip reports and provide day-to-day expert advice to CRAs • Review progress of clinical trials, especially patient recruitment and clinical trial data capture, and initiates appropriate actions to achieve objectives • Conduct Monitoring Oversight Visits ensuring clinical trial site and internal/external CRA (Clinical Research Associate) performance • Manage protocol and GCP deviations as Deviation Manager according to SOP • Proactively contributes to continuous improvement of Clinical Operation specific processes, procedure and templates