Sunny Le Email & Phone Number

Ontario, Canada

Toronto, Ontario, Canada

Ontario, Canada

Toronto, Ontario, Canada

• Establish and validate NCA, PKPD models using industry-standards tool. • Perform literature and data evaluation to provide scientific background for clinical studies design for studies from earlier development to post-market phase• Prepares the PK portion of synopses for clinical studies;• Answers inquiries in process of preparation and reviews study protocols• Performs/reviews pharmacokinetic analysis of concentration-time data with the up-to dated… Show more • Establish and validate NCA, PKPD models using industry-standards tool. • Perform literature and data evaluation to provide scientific background for clinical studies design for studies from earlier development to post-market phase• Prepares the PK portion of synopses for clinical studies;• Answers inquiries in process of preparation and reviews study protocols• Performs/reviews pharmacokinetic analysis of concentration-time data with the up-to dated software• Prepares/reviews the pharmacokinetic section of study reports• Interacts and provides input and feedback to Biostatistics Department for data analysis• Reviews statistical output to evaluate study results• Reviews study reports• Provides scientific support to other departments and teams in the area of pharmacology, pharmaceutics and pharmacokinetics• Takes part in revision of the Biopharmaceutics Department and the company SOPs; provides input into departmental practices and maintains updated the study- and report-related templates• Maintains the Biopharmaceutics Department databases; provides the department and the company with updated scientific literature and maintains regulatory guidelines updated Show less

Toronto, Ontario, Canada

• Perform literature and data evaluation to provide scientific background for clinical studies design;• Prepares the PK portion of synopses for clinical studies;• Answers inquiries in process of preparation and reviews study protocols• Involved in performs/reviews pharmacokinetic analysis of concentration – time data with the up-to dated software; • Involved in preparation/reviews, the pharmacokinetic section of study reports• Involved in interaction with biostatistics… Show more • Perform literature and data evaluation to provide scientific background for clinical studies design;• Prepares the PK portion of synopses for clinical studies;• Answers inquiries in process of preparation and reviews study protocols• Involved in performs/reviews pharmacokinetic analysis of concentration – time data with the up-to dated software; • Involved in preparation/reviews, the pharmacokinetic section of study reports• Involved in interaction with biostatistics Department for data analysis• Reviews statistical output to evaluate study results• Involved in review of study reports• Takes part in revision of the Biopharmaceutics Department and the company SOPs; provides input into departmental practices and maintains updated the study- and report-related templates• Maintains the Biopharmaceutics Department databases; provides the department and the company with updated scientific literature and maintains regulatory guidelines updated Show less

• Draft, circulate for review and approval, publish communication articles in internal social media channels;• Prepare the drug submission dossiers for pipeline products upon request;• Prepare and submit the company’s periodic reports to authorized agency;• Review and revise legal corporate documents;• Draft and translate corporate correspondence;• Ensure all corporate activities under department controlled compliance with company’s policy;• Oversee conference room… Show more • Draft, circulate for review and approval, publish communication articles in internal social media channels;• Prepare the drug submission dossiers for pipeline products upon request;• Prepare and submit the company’s periodic reports to authorized agency;• Review and revise legal corporate documents;• Draft and translate corporate correspondence;• Ensure all corporate activities under department controlled compliance with company’s policy;• Oversee conference room scheduling and prepares conference rooms for meetings;• Assist with client related meeting set up, as applicable;• Support for other administrative tasks upon request. Show less

Jun 2015-Sep 2015: Duo CRA/CTAOct 2015-Jun 2015: CRA Covance’s Appreciates for an Individual, 2016; Strong practical experience of ICH-GCP (R2) and local Regulations; Solid experience in performing feasibility, initiation, monitoring, close-out and premature close-out visits; Successful at managing 2 sites to reach their recruitment target smoothly within one week;  Experience in budget review & negotiation with sites;  Practical experience with Risk-base… Show more Jun 2015-Sep 2015: Duo CRA/CTAOct 2015-Jun 2015: CRA Covance’s Appreciates for an Individual, 2016; Strong practical experience of ICH-GCP (R2) and local Regulations; Solid experience in performing feasibility, initiation, monitoring, close-out and premature close-out visits; Successful at managing 2 sites to reach their recruitment target smoothly within one week;  Experience in budget review & negotiation with sites;  Practical experience with Risk-base Monitoring;  Experience in drafting, review and translation of protocols and other relevant documents, including but not limited to IB, ICF and SOPs; Experience in completing Serious Adverse Event (SAE)/Adverse Event (EA) reporting, process production of reports, narratives and follow up of SAEs/AEs; Strong experience with CTMS, EDC/eCRF, EMR, and IVRS; Award “Inform 6.1 Super User” in 2016; Outstanding experience in filing & maintaining eTMF and essential documents at site; Experience in preparing and escorting for inspections and external/internal audits;  Solid experience working with vendors and agencies (from vendor selection, budget negotiation, execution to contract liquidation);  Experience in oncology, infectious diseases, and rheumatoid arthritis studies;  Experience in mentor junior CRA and CTA; Ability to work under intense pressure and in a diverse workplace;  Outstanding skills in multi-tasking, problem-solving and strategic planning.  Excellent abilities in MS Office (Outlook, Word, Excel & PowerPoint), Adobe applications (Photoshop, Illustrator, Audition) and WebEx. Show less

Ho Chi Minh City, Vietnam

+ Co-monitoring & Monitoring of 1 site for local Hepatitis C study and 1 site for local Rheumatoid Arthritis study• Co-monitors with a clinical research associate in the assigned clinical trial;• Assists in doing source data verification process;• Ensures proper drug storage and drug accountability;• Protocol developing: scientific advices and updating medical information (include dosage, AEs regimen.);• Medical translating: translate, edit and quality control protocols… Show more + Co-monitoring & Monitoring of 1 site for local Hepatitis C study and 1 site for local Rheumatoid Arthritis study• Co-monitors with a clinical research associate in the assigned clinical trial;• Assists in doing source data verification process;• Ensures proper drug storage and drug accountability;• Protocol developing: scientific advices and updating medical information (include dosage, AEs regimen.);• Medical translating: translate, edit and quality control protocols (English into Vietnamese and back translate);• Prepare study SOPs, logs, templates;• Translate and edit ICF, CRF, Investigator’s brochures; • Prepare Trial Master Files Binders and Site Trial Files Binders;• Assist Regulatory Affairs and R&D department on prepare registration dossier. Show less

Post-Graduate Diploma, Clinical Research, Drug Safety & Pharmacovigilance

Bachelor'S Degree, Pharmacy

Activities and Societies: - PR's team leader of Pharmacy English Club - Participated in many activities and voluntary work held.

Diploma, English

In the associated program of Vietnam USA Society (VUS), The City University of New York (CUNY) and The college of Staten Island (CSI)