Heather Leps

About Heather Leps

Seasoned clinical operations lead with a robust background in clinical trial management and a proven track record of upholding to the highest ethical and quality standards. Adept at driving cross-functional collaboration, optimizing operational efficiency, and ensuring regulatory compliance across global and regional clinical projects. Committed to excellence in patient safety, data integrity, and strategic execution.

Experience

1. Senior Clinical Operations Lead

   IQVIA

   Feb 2021 — Present

   Global Lead managing North America, APAC, and EU countriesOversee the execution of Start Up and Maintenance for assigned projects in accordance with the agreed Start Up strategy, budget, and Clinical Operations Plan. Develop & maintain clinical project plans, including but not limited to i.e. Regulatory Start Up Management Plan, Clinical Operations Plan, Recruitment plan Real World Evidence Group resource request review and alignment from project award and during entire duration of the projectAccountable for the operational delivery (site activation, subject recruitment, site management, data integrity, project quality, database lock, study closure) of assigned portion of clinical studiesEnsure overall project efficiency and adherence to project timelines and financial goalsResponsible for the functional financial delivery of the project

Education

• Saint Joseph's University

  M.S., Experimental Psychology/Specialization in Health Psychology

• Saint Joseph's University

  B.S., Psychology