Sandy MacNicoll

Background

About Sandy MacNicoll

Accomplished clinical research professional with extensive experience leading study start-up operations for both investigator-initiated and industry-sponsored trials. Skilled in coordinating site feasibility, managing regulatory documentation, and driving submission accuracy across multiple therapeutic areas and protocols. I bring a strategic and detail-oriented approach to navigating complex timelines while ensuring full compliance with ICH-GCP, Good Documentation Practices, and institutional requirements. With a strong track record of successful submissions to IRBs, sIRBs, and health authorities—including WCG Connexus and Advarra—I consistently ensure audit readiness through meticulous oversight of trial master files and documentation. My background includes mentoring study staff, collaborating with cross-functional teams, supporting vendor contracts, and onboarding investigators to ensure seamless study launches. Passionate about advancing clinical research through operational excellence, I’m dedicated to improving site preparedness, regulatory alignment, and overall trial efficiency.