Lydia Li

acting as the Head of Clinical Research department. Oversight CRO and over vendors clinical study related progress. Training and interview new PMs

Responsible for overseeing all operational aspects of monitoring and site management activities for the assigned Phase III internally monitored and outsourced clinical trials for Bayer Global Clinical Development. The SML is a core member of the Study Team, representing Global Monitoring and Site Management as well as the Clinical Trail Investigators and Site Staff. Advisor to Study Team as expert in all operational aspects of conducting a clinical trial from the monitor and Investigator perspectives. Ensures study processes and expectations correspond to the practicality of conducing the trial from the operational perspective, from study feasibility to study close out. Leads and manages the assigned Country Lead Monitors (CLMs) and CRAs globally. Collaborates with GCO-Business Management (GCO-BM) & Operational Oversight-GCO (OO-GCO) to develop Monitoring and Site Management component of the Operational Quality Oversight Plan if required, Data Verification Initiatives. Conducts co-monitoring visits and reviews Periodic Monitoring Visit Reports according to the Operational Quality Oversight Plan. Is an active member of the Fraud &Misconduct Team and/or Inspection Team,Responsible and accountable for developing the study specific Monitor Training Plan and Investigator Site Training Plan. Obtains requisite functional and legal/compliance approvals and coordinates activities related to multi-center Monitor and Investigator Site Training Meetings. Accountable for developing Monitor training materials, ensure study specific training of Monitors, trains new Monitors to the study and reviews and approves training content changes. Develops Investigator and Site staff training material for functional and operational study activities. Makes presentations as assigned at Investigator Site and/or Monitor Training as assigned. Give support to audit activities.

Assisting with preparation of protocols and other necessary documents required for trial approval by HA. Preparing protocols and other necessary documents required for trial approval by EC and get EC approval on time.Monitoring and coordinating the clinical trial conduction in whole process by following GCP and SOP strictly.Giving input to query resolution, site closure and collection of documentation required for clinical trial reports after trail end.Ensuring IMPACT, EDC system for administration of clinical trials is updated in a timely and accurate manner in accordance with requirements.Ensuring all SAEs/adverse drug reactions are reported and followed up in a timely manner according to internal relevant SOP.Maintaining, updating and archiving all clinical trial files on time. Project Plan and Team Training. Review CRA’s monitoring reports. Make the budget & budget tracking and control.

4 years "first scholarship" in the college. "Excellent Graduate"