Tingting Duan
10+ years of experience across clinical operations, clinical research and drug discovery for CRO, clinical site and research institution | Neuroscience, Oncology, Hematology, Immunology, Rare Disease
- Role
- Associate Clinical Trial Manager at Medpace
- Location
- Pittsburgh, PA, US
- LinkedIn followers
- 500 followers
About Tingting Duan
I have 3+ years of experience in the Clinical Research field, including 1 year of patience-facing experience as a Lead Study Coordinator at Clinical Site and 2+ years of CTM experience at CRO with therapeutic focus on Neuroscience, Oncology, Immunology, Hematology and Rare Disease across Phase I-IV. I also have 5 years of experience in drug discovery by participating in a project of screening small molecules for their potential as antidepressants. Open to opportunities and always excited to connect via LinkedIn or t••••••••@gmail.com
Experience
Associate Clinical Trial Manager
Oct 2022 — Present · Cincinnati, OH, US
Manage and oversee clinical studies for biotech and Pharma in compliance with ICH/GCP guidelines and other regulatory requirements Lead and manage cross-functional study teams to accurately coordinate clinical study activities Review and provide input for Study Protocol, Investigator’s Brochure, Informed Consent Form, Case Report Form, Edit Check Specifications, Data Analysis Plan, Clinical Study Report Collaborate cross-functionally to monitor study data related activities including data review, query creation and resolution, study and protocol deviation reviews, safety reviews Assist Medical Monitors in preparation of the responses for PIs (Principal Investigators) and Regulatory Authorities Manage site quality to maintain 100% compliance with ICH/GCP guidelines and study protocols, including direct supervision of Clinical Research Associates and monitoring deliverables Lead the preparation for Investigator Meetings, Site Teleconference Meetings, DMC meetings Assist TMF team in overseeing the entire TMF process, ensuring timely completion and accuracy of all essential documents Assist in the preparation and submission of regulatory documents for US, Canada and EU
Education
University of science and technology of China
Doctor of Philosophy - PhD
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