Experience

Oxford University Clinical Research Unit

• Vietnam
• Research Services
• 200 - 300 Employee

• • Feb 2023 - Present

• • Jul 2021 - Mar 2023



Eijkman Oxford Clinical Research Unit

• Salemba, Jakarta Pusat

• Clinical Trial Coordinator

  • Jul 2020 - Jul 2021



AstraZeneca

• United Kingdom
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Clinical Research Associate

  • Jul 2019 - Mar 2020



IQVIA

• United States
• Hospitals and Health Care
• 700 & Above Employee

• • Nov 2015 - May 2018

  • CTMS champion for Quintiles Asia Pacific• Site selection visit, site initiation visit, site monitoring visit, site close out visit• Regulatory start up• Experienced in dengue vaccine study, cardiovascular study, lupus study• Participated in sponsor audit and regulatory authority inspection

• • Feb 2010 - Oct 2015

  • Site initiation visit, site monitoring visit, site close out visit• Manage project as global flexible resources• Feasibility study• Experienced in vaccine study, cardiovascular study, chronic pulmonary obstruction study, peptic ulcer study, and contributing in survival follow-up phase of non-small cell lung cancer.• Participated in sponsor audit and regulatory authority inspection.



PT Equilab International

• • May 2009 - Feb 2010

  • Site initiation visit, site monitoring visit, source data verification using paper CRF, and site close out visit.• Start up activities: investigator meeting preparation and protocol dossier submission to regulatory authority/ ethics committee. • Experienced in diabetic mellitus and incontinence study.

• • Sep 2008 - May 2009

  • Responsible for protocol development, literature analyze of pharmacokinetics and pharmacology drugs profile.• Data management analysis to conclude bioequivalence result of generic product against the patent.• Analyzing pharmacokinetics data statistically to justify final decision of bioequivalence result.• Acknowledged and understanding bioequivalence study guidelines among other countries.• Experienced work with regional/ europe pharma company. • Participated regional/ europe pharma audit.• Achievement: Journal publication with project team for bioequivalence study of anti-infectious and anti-inflammatory drugs. Show less