Clinical research professional and consultant with 20 years of experience supporting and managing IVD clinical studies, diagnostics and device studies and biobanking projects, in accordance with sponsor budgets and timelines and with emphasis on effective communication with sponsors, sites, and vendors.Familiar and experienced with logistical, ethical, and collaborative challenges of clinical studies, from planning and initiation to specimen and data delivery. Experienced with a full range of studies from early R&D phase sample collection to full GCP prospective trials that achieved FDA approval.My services may include:* Planning, setup and end-to-end project management of prospective IVD studies sponsored by US and international (Europe, Asia) diagnostics companies.* Budget development, contract and budget negotiation; clinical site qualification, initiation, and management; project tracking and reporting.* Study data management including database design and testing, data monitoring, and final data delivery.I work on an hourly short or long term contract basis through my company, MaasBio, or in partnership with my colleagues at Global BioClinical. Whether you are seeking full-service management of a clinical study or simply need to supplement your own team temporarily in order to complete a project, I can help you customize and scale a package of services to meet your needs.