Lena

Experience

1. Clinical Project Manager

   IQVIA

   Nov 2022 — Present

   Accountable to deliver Trial(s) on time, within budget, and with highest achievable quality.• Assist in the review, development and/or writing of clinical trial documents and manuals, including but not limited to Protocol, Case Report Forms, informed consent forms, Clinical Study Report and other regulatory documents.• Lead the evaluation and selection of investigative sites; responsible for feasibility.• Select, coordinate and monitor activities of vendors Review of monitoring reports and conduct co‐ monitoring visits, as needed.• Develop and manage trial(s) timelines, budget and priorities.• Participate in data review and discrepancy resolution.• Ensure set up and maintain all systems in order to plan and implement trial(s) and track progress.• Generate reports to update management on conduct of trial.• Ensure appropriate clinical trial supply plans are implemented and managed.• Develop recruitment plans, risk‐mitigation plan, monitor, and implement contingencies as required.• Participate in monitoring study safety.• Review key study quality metrics (e.g, eligibility, primary endpoint data, etc.) and determine appropriate action in conjunction with study team.• Perform initial review of CRO and other third party study vendor invoices to ensure that work is performed in accordance with scope of work.• Assist with CRA and third party vendor training on protocols and practices.• Lead the multi‐disciplinary trials teams; include the study team meetings.• Function as the primary contact for trial(s) between Drug Development and other departments.• Assume responsibility to participate as a member of working groups and perform special projects, as assigned.• Ensure adherence to Good Clinical Practice and all applicable local and international regulations.

Education

• University of North Carolina Wilmington

  Bachelor of Science (B.S.), Clinical Research

  2013 — 2017