Sein(Senna) Lee Email & Phone Number

Hayward, California, United States

Oncology - APAC- Facilitate effective communication between internal teams, study sites, and external vendors to ensure successful trial execution.- Responsible for tracking study progress, updating stakeholders, and maintaining essential documentation.- Collaborate with clinical project/trial managers, and other stakeholders to ensure that all trial objectives are met in a timely and efficient manner.- Assist in the preparation of trial materials and reports to support decision-making at various stages of the trial.

Seoul, South Korea

- Primary point of contact at a country level for assigned studies and has operational oversight of assigned protocol(s) from start-up through to database lock and closeout activities. - Responsible for coordinating and leading the local trial team to deliver quality data and trial documents/records that are compliant with the assigned clinical trial protocol, company Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and regulatory requirements.- Contributes input to the study management documents at a country level or initiates development ofthese documents for a single country trial, as per SOPs. - Leads and coordinates local trial team activities in compliance with SOPs, other procedural documentsand applicable regulations. Leads local project planning activities to meet recruitment targets and todeliver high quality data on time and within study budget. Including but not limited to: development oflocal trial specific procedures and tools, recruitment planning, contingency and risk management, andbudget forecasting.

Seoul, South Korea

- Primary contact point between the Sponsor and the Investigational site. Assigned to trial sites to ensure inspection readiness through compliance with the clinical trial protocol, company Standard Operating Procedures (SOP), Good Clinical Practice (GCP), and applicable regulations and guidelines from study start-up through to site closure.- Responsible for assisting with site selection, pre-trial assessment, subject recruitment and retention planning, site initiation, on-site and remote monitoring and close-out activities. Collaborate with the Local Trial Manager (LTM), Clinical Trial Assistant (CTA) and Clinical Trial Manager (CTM) to ensure overall site management while performing trial related activities for assigned protocols.- Review study files for completeness and ensures archiving retention requirements are met, including storage in a secure area at all time and participate in the IEC/IRB submission and notification processes as required/appropriate in required timelines.- Responsible for ensuring high quality of Local Medical Depot as per local regulation and internal SOPs collaborated with Janssen Korea’s controlled substance manager. Developed new ‘local guidelines for Narcotic Handling procedure for clinical trial’ and supported MFDS inspection and internal audits.- Mentored junior SMs to develop their competency by having bi-weekly 1:1 meeting for a year and led 4 times of SM knowledge session to review full contents of KGCP and FAQ for clinical trials released by MFDS.- Contributed as an SST/LMS champion in process development for site staff training management system (DrugDev) and a member of GCDO APAC times in releasing APAC’s highlights/news.

Seoul, South Korea

- Primary contact point between the Sponsor and the Investigational site. Assigned to trial sites to ensure inspection readiness through compliance with the clinical trial protocol, company Standard Operating Procedures (SOP), Good Clinical Practice (GCP), and applicable regulations and guidelines from study start-up through to site closure.- Responsible for assisting with site selection, pre-trial assessment, subject recruitment and retention planning, site initiation, on-site and remote monitoring and close-out activities. Collaborate with the Local Trial Manager (LTM), Clinical Trial Assistant (CTA) and Clinical Trial Manager (CTM) to ensure overall site management while performing trial related activities for assigned protocols.- Ensure that all Adverse Events (AE) /Serious Adverse Events (SAEs)/ Product Quality Complaints (PQCs) are reported within the required reporting timelines and documented as appropriate. For AEs/SAEs, ensures that they are consistent with all data collected and with the information in the source documents.- Contributed as an SAE reporting trainer in SM Skill Enhancement training/ meetings to raise awareness of the importance and SAE TFT team collaborated with PV to improve current process.- Review study files for completeness and ensures archiving retention requirements are met, including storage in a secure area at all time and participate in the IEC/IRB submission and notification processes as required/appropriate in required timelines.

South Korea

- Main contact with healthcare professionals meeting both the business and scientific needs. - Establish new business and negotiate contracts. - Present products to healthcare staff including doctors, nurses and pharmacists. Manage budgets and review sales performance.