Aaron Bjugstad

About Aaron Bjugstad

Experienced in study conduct, monitoring, and trial management of clinical drug and device studies in a wide range of therapeutic areas, in all phases of research, with study subject recruitments ranging from very few subjects to several hundred subjects per study.• Fluent in many data collection programs such as: Medidata (Classic and Rave), Excel, Study Monitor, Oracle, Timeaus, Cmed, QCTMS, Epic, Cerner and SPSS. • Proficient in training of sites, study staff, or colleagues and have conducted large and small group presentations for clients, sponsors, and internal training. • Skilled at organizing, creating, negotiating and fulfilling contracts and budgets using external resources in order to complete the needs of the studies, sponsors and sites and to ensure that all parties contracted are performing according to GCPs, FDA regulations, and IRB mandates.• Proficient in study regulatory requirements, source document creation, protocol development and review, and ICH/GXP Guidelines.• Experienced at clarifying, interpreting, and reviewing protocols in order to recognize difficult study conduct situations ahead of study conduct start to ensure to maximize protocol compliance and minimize protocol deviations.• Accomplished at presenting for sponsors of varying backgrounds and conducting staff training sessions for protocol and SOP compliance training. • Skilled in directing multiple clinical teams to conduct simultaneous studies and experienced in managing multi-site studies across several countries in order to achieve a singular goal of conducting a successful study.

Experience

1. Sr Project Manager

   Premier Research

   May 2024 — Present

Education

• University of North Dakota

  Bachelors of Science, Biology, Psychology

  2000 — 2008