Ze Li
Global Study Manager @ Clincierge
About
Certified Project Management Professional (PMP) with 10+ years of experience in clinical trial operations across a multitude of therapeutic areas and indications.
United States
Ontario
Research
Query Resolution, Project Leadership, Clinical Study Management, Written Communication, Electronic Data Capture (EDC), Clinical Operations, Teamwork, Resource Allocation, Regulatory Requirements, Project Plans, Pharmaceuticals, Project Management, Research, Molecular Biology, Science, Data Analysis, Biochemistry, Cell Culture, Life Sciences, PCR
Experience

Global Study Manager
Philadelphia, Pennsylvania, United States
• Served as operational project manager in support for clinical trial patients, providing prepaid travel assistance, international relocation support, interpretation, payments, reimbursements, etc. • Managed portfolio of 10+ clients in the global clinical trial space with varying needs and requirements • Ensured projects reached achieved milestones / deliverables as scheduled • Facilitated communication between clinical trial sponsors, CROs, sites, and internal functional team members to provide updates and manage expectations • Administrated high value project budgets as project manager, formulating action plans and change orders as needed • Reviewed internal study spend on behalf of clients and negotiated with vendors to determine most cost-effective options • Led global team of Clincierge Coordinators in providing high quality service to participants • Maintained adaptive approach to issue management of errors and queries, performing Root Cause Analyses and drafting Corrective and Preventive Actions as needed • Ensured adherence to appropriate regulatory compliance in relevant projects, following specific regional requirements as needed • Assisted in project-specific plan/document drafting during study start-up and maintained throughout project lifespan • Worked alongside process documentation committee to devise process for new documentation platform, drafting new procedures for platform usage • Identified internal process gaps in SOPs/Work Instructions and delegated authoring/co-authoring responsibilities, serving to minimize and handle outdated/obsolete documentation • Conducted department-specific and position-specific trainings for new, associate, and contractor employees

Ocular Disease Evaluator II-Lead
• Evaluated the progression of ocular disorders for clinical trials under the Doheny Image Reading Center • Operated specific medical equipment and software programs designed to analyze retinal diseases • Functioned as department lead and senior evaluator, serving as instructor and adjudicator to junior employees, training new employees on relevant core and study-specific evaluation protocols and proper GCP/GDP to maintain data integrity and quality for clinical trial patients • Managed personal and team caseloads and facilitated communication with other functional departments as well as in-department to achieve target deadlines • Participated in meetings with clinical trial sponsors as subject matter expert • Managed and updated patient data on electronic case report forms in data management systems • Assisted in document creation and revision to ensure quality of department knowledge base, reviewing for general informational consistency • Ensured quality assurance of outgoing data by assessing accuracy of ODE work and identifying areas needing improvement, with resulting individual conversations with ODEs/Investigators or department-wide email notifications to review issues and resolutions • Assisted in risk assessments and SDLC for the installation or upgrade of new software/hardware
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