April Ramirez

Senior Clinical Project Manager @Indivior

Remote - Denver, CO, US

Independently lead and coordinates the execution of one or more complex clinical studies from study start-up through data reporting (Tables, Listings and Figures, and CSR) and inspection readiness to ensure timely delivery of quality study data within agreed upon budget and timelines • Mentor Clinical Project Managers and Clinical Research Associates in all aspects of clinical study oversight. • Lead process improvement activities, i.e. identifying systems and tools, developing and maintaining standard operating procedures, work instructions and templates necessary to execute clinical programs flawlessly and to ensure adherence to regulatory requirements (ICH-GCP) and industry standards. • Work closely with the QA department to ensure quality and adherence to pertinent SOPs and guidance. Working with vendors, sites and CROs to resolve audit and inspection findings in conjunction with the QA department• Lead the RFP process, vendor selection, development of the study contract, transfer of regulatory obligations (TORO) in accordance with the bid and applicable SOPs, and work with QA and Compliance functions to qualify selected vendors.• Lead the development of the protocol; Ensure that all aspects of clinical research protocols are properly planned and executed according to regulatory requirements (e.g. ICH, GCP) and provide recommendations regarding the operational feasibility of selected study designs

Project Management Institute

Project Management Professional

Community College of Aurora

Bachelor of Applied Science (B.A.Sc.)