Participate in the preparation of vendor requirements andproject scope and selection of study vendors; effectivelymanage interactions with the vendor study team Work on study feasibility assessments and selection ofcountries and sites for study conduct Create and conduct training sessions including investigatormeetings and team trainings Provide oversight and direction to study team members,including vendors, for study deliverables Ensure all works adhere to ICH/GCP guidelines and complywith company SOP's Mentor junior members of the team Research and identify research related issues anddiscrepancies when evident and appropriately escalate to sitemanager, Director, and/or principal investigator for

Responsible for all aspects of site management as prescribedin the project plans Ensured the study staff who will conduct the protocol havereceived the proper materials and instructions to safely enterpatients into the study Acted as primary local company contact for assigned sites forspecific trials. Executed activities within site initiation and start-up, sitemonitoring, site management and site/study close-outaccording to internal SOPs and policies. Ensured site staff are trained and the corresponding trainingrecords are complete and accurate at any time point during alltrial phases. Contributed to site level recruitment strategy and contingencyplanning and implementation in partnership with otherfunctional areas to achieve clinical research target. Ensured site study supplies (such as Non-IP, lab kits, etc.) areadequate for trial conduct.

Collected, Processed and tracked regulatory documentationas required by the sponsor, FDA and other national regulatoryauthorities. Processed patient recruitment and visit scheduling, completedpatient records and completed patient visit assessment. Completed CRF and electronic data entry. Created and maintained clinical study files/source documents. Coordinated clinical trials, set-up study specific procedures,screened patients, followed-up and managed data collectionon patients involved in sponsored clinical trials. Prepared approval applications to the Investigational ReviewBoard (IRB) and other governing agencies. Maintained subject confidentiality Oversaw day to day operations, advertisement, recruitment,compliance and completion of clinical trials.

Collected, Processed and tracked regulatory documentation as required by the sponsor, FDA and other national regulatory authorities.Processed patient recruitment and visit scheduling, completed patient records and completed patient visit assessment.Completed CRF and electronic data entry.Created and maintained clinical study files/source documents.Coordinated clinical trials, set-up study specific procedures, screened patients, followed-up and managed data collection on patients involved in sponsored clinical trials.Prepared approval applications to the Investigational Review Board (IRB) and other governing agencies.Maintained subject confidentialityOversaw day to day operations, advertisement, recruitment, compliance and completion of clinical trials.