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Lily Caglianone

@lilycaglianone

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Clinical research operations consultant at iNGENū CRO, improving quality systems across a 29-trial portfolio.

United States

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What I'm looking for

I’m available for contract work that can be remote, hybrid, or based in Chicago.

At iNGENū CRO, I support clinical operations, quality, vendor oversight, and regulatory compliance across a 29-trial drug and medical device portfolio. I assess study quality plans and lead remediation across approximately 260 controlled documents, standardizing workflows across 15 operational functions.

I also qualify and oversee CROs and external clinical research vendors, conduct audits, and manage quality events, CAPAs, and audit responses. My work spans Phase I–IV industry-sponsored, NIH-funded, and investigator-initiated trials from feasibility through close-out.

At Lurie Children’s Hospital, I managed 10–15 new study intakes per week, coordinating investigators, sponsors, CROs, and regulatory teams to move studies from feasibility through activation. At Rush University Medical Center, I served as the sponsor-facing project manager for an industry trial and developed recruitment strategies that enrolled 50 participants within three weeks.

At University of Illinois at Chicago, I directed quality and regulatory strategy for multi-site trials and established risk-based monitoring processes. As a Clinical Trials Manager there, I managed five concurrent trials and increased participant randomization by 59% while maintaining 95% retention. I’m PMP- and ACRP-certified and hold an MS in Clinical Research from Rush Medical College.

Experience

Work history, roles, and key accomplishments

Current

Quality Assurance Manager

Current

iNGENū CRO

Jun 2026 - Present (4 months)

Independent contractor supporting clinical operations, quality, vendor oversight, and regulatory compliance across a 29-trial portfolio. Leads QMS remediation, authoring SOPs, and managing audits and CAPAs.

Clinical Research Study Start-Up Specialist

Lurie Children’s Hospital

Jun 2026 - Sep 2026 (3 months)

Managed 10-15 new study intakes per week, directing industry and investigator-initiated trials from feasibility through activation. Coordinated investigators, sponsors, CROs, and regulatory teams to resolve activation barriers.

Study Start Up Feasibility Site Activation CTMS Regulatory Submissions Stakeholder Management Process Improvement

Industry Project Manager

Rush University Medical Center

Dec 2025 - Feb 2026 (2 months)

Served as primary sponsor-facing PM for an industry trial from start-up through close-out, owning timelines, risks, budgets, and escalations. Developed recruitment strategies that enrolled 50 participants within three weeks.

Clinical Project Management Budget Management Risk Management Recruitment Database Lock Vendor Oversight Inspection Readiness

Independent Research Consultant

Aug 2025 - Nov 2025 (3 months)

Supported manuscript development and peer review projects.

Manuscript Development Peer Review

Quality Assurance & Regulatory Operations Manager

University of Illinois at Chicago

Sep 2024 - Aug 2025 (11 months)

Directed quality, regulatory, and operational strategy for multi-site NIH-funded and industry trials. Led inspection readiness through internal audits, root-cause analysis, CAPA development, and corrective action implementation.

Quality Assurance Regulatory Operations Risk Based Monitoring CAPA Audit Vendor Management Budget Management National Institute of Health Clinical Trials

Clinical Trials Manager

University of Illinois at Chicago

Sep 2023 - Sep 2024 (1 year)

Managed five concurrent NIH-funded and industry-sponsored trials from start-up through enrollment, database lock, and close-out. Increased participant randomization by 59% while maintaining 95% retention.

Clinical Trial Management Database Lock TMF Regulatory Documentation Cross functional Leadership Vendor Management

Research Associate II

University of Illinois at Chicago

Sep 2022 - Sep 2023 (1 year)

Supported research program start-up through IRB submissions, protocol development, SOPs, regulatory documentation, and onboarding. Contributed to study design, data analysis, and peer-reviewed publications.

IRB Submission Protocol Development SOPs Regulatory Documentation Study Design Data Analysis Publications