Experience

QPS Holdings, LLC

• United States
• Pharmaceutical Manufacturing
• 300 - 400 Employee

• Senior Data Manager

  • Sep 2017 - Present

  SUMMARY•Over 6 years of experience working in the clinical research industry.•Joined QPS-Qualitix Clinical Research since Sep 2017•Experience with electronic data capturing (EDC) systems: OpenClinica, Rave and RESIN• Lead Data Manager for 18 studies, including 11 global studies•Supporting Data Manager for 14 studies, including 5 global studies•Current and previous experiences in therapeutic areas include,Therapeutic Area/Indication Name:1.Dermatology/BE2.Endocrinology/Hypogonadism3.Genetic Disease/Wilson's disease (WD), Fanconi Anemia4.Healthy Volunteer/Autoimmune and inflammatory diseases, Acoustic Trauma, Cancer, Central stimulant, Common Cold, Diabetes, Diabetic Retinopathy, Glaucoma, Hepatitis B, Improve cognitive function, mood states, and mental performance, Intermittent Claudication, Migraine and Cluster Headaches, Non-small cell lung cancer (NSCLC), Postoperative inflammation and pain5. Oncology/Breast Cancer, Glioblastoma multiforme, HCC or CRC with liver metastases, Non-small cell lung cancer (NSCLC), Hepatocellular carcinoma (HCC)6. Psychiatry/ Schizophreina7. Respiratory Diseases/ Chronic obstructive pulmonary disease (COPD) Show less

• Senior Data Manager

  • Sep 2017 - Jan 2023



National Taiwan University Hospital

• Taiwan
• Medical Practices
• 300 - 400 Employee

• Clinical Study Coordinator

  • Jun 2014 - May 2017

  Clinical Research Experience 1.Pharmacokinetics and safety studies of esomeprazole combined clozapine use in schizophrenia patients 2.Esomeprazole add-on treatment for schizophrenia: a randomized, double blinded, placebo controlled study 3.Discover imaging biomarkers for early diagnosis of schizophrenia and prediction of drug response using whole brain connectogram analysis (I-III) 4.A Neurobiological study on heterogeneity of schizophrenia: genetic variations and neurobiological differentiations (2) Professional Experience Prepared and submitted materials for new and ongoing clinical trials to ethics and other bodies for approval Designed informed consent, case report form, subject information sheets Followed up review status, replied comments and obtained approval letters Obtained and maintained submission materials Assembled materials and binders for meetings and attended pre-study training Screened and recruited subjects Recorded documents accurately and safeguarded confidentiality of subjects Obtained, secured and shipped blood specimens in accordance with protocol Collected and recorded subjects’ data and reported abnormalities to the Principal Investigator Recorded and submitted counting reviews, adverse events, serious adverse events and final reports in a timely manner Reviewed medical records and case report forms to ensure accuracy and completion Maintained Trial Master File throughout a study Worked with study team and CRA to identify resolve and prevent issues Made preparations for monitoring visits Scheduled team meetings and documented notes monthly Built up strong rapport with the subjects and their families Demonstrated good knowledge of Microsoft Office applications, PTMS and CSIS Reviewed study related documents recorded completely and accurately Submitted final reports Disposed used and unused laboratory and study supplies Made sure investigational agents destroyed by pharmacist Show less



Wang Fang Medical Center

• Taipei City, Taiwan

• Registered Nurse

  • Sep 2012 - Feb 2014

   Was able to provide nursing care adequately by observing, assessing and reassessing accordingly  Provided patient education by identifying patients’ limitation and strengths  Demonstrated professionalism at all times and was able to manage time efficiently  Was able to provide nursing care adequately by observing, assessing and reassessing accordingly  Provided patient education by identifying patients’ limitation and strengths  Demonstrated professionalism at all times and was able to manage time efficiently