Clinical Trial Lead
IQVIA
Jun 2021 - Present
► Prevented a projected 18% budget overrun by using a bottom-up EAC as an early warning system; led an RCA to identify hemolyzed samples (central lab scope creep) as the root cause, implementing a fix that saved the budget and data quality.
► Led an emergency crisis-response to the war in Ukraine, securing 24-hour sponsor approval and managing a new vendor to transfer all original ISFs from Kyiv to a secure facility in Poland with zero data loss.
► Led a "tiger team" to resolve complex, high-risk CTIS RFIs from France & Spain, creating a "consistency matrix" to ensure 100% on-time, non-conflicting submissions and secure study approval.
► Facilitated a high-stakes sponsor audit that concluded in 3 days with zero major or minor findings by fostering an "always-ready" quality culture and proactively presenting a transparent analysis of known TMF gaps.
► Proactively identified a critical protocol barrier (caffeine restriction) by presenting cultural and operational risk data, successfully influencing the medical team to remove it and securing a top-enrolling site.
CRO Oversight Lead
Alexion
Feb 2020 - May 2021
► Solved a "study-killer" roadblock by securing the only eligible diagnostic facility in the country; led a cross-functional team (logistics, contracts) to coordinate complex patient travel (3000km), achieving the first patient enrolled globally.
► Championed a new TMF quality control system (weekly scorecard, accountability calls) to address poor performance, driving completeness scores to 97% ahead of schedule and successfully passing a pre-inspection QA review.
Professional development
Career Break
Sep 2019 - Jan 2020
► Professional development – Data Analytics with R (programming language)
Clinical Project Manager
SDD
Sep 2018 - Aug 2019
► Pivoted from a regulatory roadblock in Kazakhstan by sourcing, vetting, and contracting a local freelance CRA to manage an evolving submission process, avoiding a major study delay.
RWE Study Lead
AbbVie
Jul 2016 - Aug 2018
► Championed and implemented a new vendor-hosted agile "Study Project Dashboard"; built the business case, secured IT/Finance approval, and drove adoption, reducing start-up timelines by 3 weeks.
► Led a successful turnaround of a low-performing Data Management CRO by mapping a clear remediation plan and new SLAs, improving data quality and meeting all interim database milestones.
► Designed and implemented a dynamic R/Y/G site health dashboard and bi-weekly review process, shifting the team from "firefighting" to proactive management and reducing late deliverables by 35%.
► Led cross-functional alignment (Medical, Biostats, Marketing) for a large epidemiological study publication, translating diverse stakeholder needs into a unified data narrative used to successfully present drug advantages to the government.