Lisa Li

Service as point of contact for sponsor and manage all aspects of the trial process. Drive study startup, enrollment, and closeout. Manage study scope, budget, and timelines. Work with other functional groups to ensure that timelines, budgets and study objectives are met.

Coordinate, prepare, and review IB and regulatory submissions (Pre-IND briefing package, IND amendment and Annual Report) of company products. Communicate with regulatory agencies. Develop SOPs.

Manage day to day clinical study activities including budget negotiations, site selection, initiation, enrollment, site management and monitoring (if needed), protocol compliance, trial master file maintenance, data management and study close-out. Oversee study monitoring activities of CRAs supporting assigned programs/studies. Develop and maintain effective communication with Vendors. Facilitate protocol and related document development. Ensure compliance with appropriate regulatory (GCP, FDA, ICH etc.) and internal SOPs and guidelines.

Responsible for day to day activities throughout clinical trial. Works cross-functionally with internal teams and vendors. Oversee CRAs to ensure that studies are conducted per protocol and on time.• Provide data interpretation support to the Medical/Scientific writing team for all medical/scientific documents. Propose and implement novel analytical strategies to maximize value of clinical trial results. Review analyses of study results to ensure accurate data reporting. Work with medical writer with the completion of CSR. Prepare clinical data for presentation at external scientific meetings.

Responsible for setting up trials and present operation procedure to client. Develop client relationship development. Ensure communication and coordination of timelines for internal and external functional units. Assist with data interpretation and report writing.