Chien-I Chen

In 2015, working as Associate Research Fellow about new drug research in Development Center for Biotechnology. Strong project management ability and very familiar with GCP. Join IQVIA since 2016, familiar with preparing IRB submissions of amendments, closure reports, interim reports and Safety report and good communication with IRB staffs. Also, has experience with managing ISF, eTMF and site patient binders. Attending the handover meeting with RSU team for pre-SIV preparation. Has capability of communication and negotiation with site staffs for data queries and follow-up. Able to learn and apply new concepts quickly and effectively. With very strong project and timeline management skills. Good communication with internal and external people. Excellent interpersonal skills to always create win-win strategies. Confident, independent and always willing to take on new challenges. Experienced CTA with over 4 years of experience in IQVIA . Excellent reputation for resolving problems and well cooperation with team members .

Clinical Research Associate:

· Support KSCGMH to deal with CTC audit and CAPA closing in 2019.

· Global DBL on time, 2019

Clinical Trial Assistant:

· Support study data update and completed on time.

· Achieve more than 90% eTMF completeness within interim file review.

· Complete all the action items for the studies.