黄甜甜 Email and Phone Number

Study ManagementDec.2020~now To manage a BE trial enrolling healthy people, from protocol preparing to DBL.Jan.2021~now To manage a bispecific monoclonal antibody phase I study, support FDA and NMPA IND, site selection, CRO biding, vendor choosing. I see operation team can also contribute to early stage of a trail.Oct.2020~Dec.2020 Be in charge of a Multi-center, NSCLC, Phase III bridging Study, prepare for site initiation. The trail is suspended because of IND approve letter delay. Quality Control ManagementJan.2021~now Develop on-site QC SOP with QC manager, make QC Plan for 3 NDA subimission trials, pay more attention to RBM(risk-based monitoring) in QC process according to our department head’s consideration, conduct on-site QC for each study personally.Personnel ManagementJan.2021~now Manage 2 employees, a QC manager and an APM.

Jul.2019~Sep.2019 Support two first-in-class’s FDA and NMPA IND application and its carrying out, one drug’s target indication is solid tumor, the other’s is lymphoma. My work includes protocol modification, vendor management(centrol lab and CRO) and reviewing management documents.Oct.2019~Jul.2020 Be in charge of a Multi-center, Phase II/III ES-SCLC Study from site initiation to fist dose SMC meeting during outbreak of COV-19. We did good job.Sep 2019~Aug.2020 Be in charge of a mass balance study enrolling healthy people from protocol design to HGRAC reviewing meeting. This trial is delayed due to Cov-19.

APM Jan.2017~Jun.2019 Support two Diabetes Mellitus Phase III studies and a Hyperuricuria Phase II Study, in charge of people Management, document management, quality control, process management(contract, HGRAC) and preparation of reporting materials. It is a good chance to learn different management styles and strong points from experised PMs.PMJul.2018~Jun.2019 Be in charge of An Diabetes Mellitus Phase III study, focus on data cleaning including query resolving, SAE checking, coding check, QA audit, PD collecting, account management, to make sure the data is completely cleaned for NDA submission.Jan.2019~Jun.2019 Be in charge of a Renal Anemia Phase I Study, and prepare for site initiation including drug preparing, vendor choosing (randomizing, central Lab, SMO, recruitment, Statistics), contracts, Consumables application, CED registration, clinicaltrail website registration.

May.2014~May.2016 SCRA for a FDA ANDA (abbreviated new drug application) study for its world’s first generic drug called Libaoduo (an anti-tumor drug, the branded drug is Doxil). My duty is to cooperate with quintiles (CRO), Wuxi AppTec (Central Lab) and SMO company to check the quality, and to deal with all kinds of audits like mock FDA audit, third party audit, lab audit. Jan.2016~Dec.2016 SCRA for a phase Ib study on a biological product to treat Rheumatoid Arthritis.

CRA for 3 studies and completed them all, they are Alzheimer’s disease study, Diabetic Nephropathy study, Asthma study. In this period I learned about monitoring in global pharmaceutical company, especially many kinds of trail-related software systems.

Jun.2010~Dec.2010 CTA for Alcon’s Open-Angle Glaucoma and Ocular Hypertension study. Dec.2010~May.2012 CRA for Meiji’s Acute tonsillitis and sinusitis study on the children, a phase III study. Complete the study from site selection to site close out in turn, during 2 years, 5 sites.May.2012~Oct.2012 CRA for Otsuka’s cardiac edema phase III study, enroll the most patients in the early time. 6 sites.