AMY WARNER
Evansville,IN
Summary
Clinical Project Manager leading clinical trial delivery from planning through closeout, with responsibility for scope, timeline, cost, and quality across assigned studies. Partners with sponsors and internal teams on feasibility, proposals, budgets, and operational execution while driving risk mitigation, compliance, and client alignment.
Overview
13
13
years of professional experience
Work History
Project Manager
ICON plc
Blue Bell, PA
12.2024 - 08.2026
- Led cross-functional project teams, managed client expectations, and maintained clear internal and external communication to support client satisfaction and study delivery.
- Identified, assessed, mitigated, resolved, and escalated project risks and issues to ensure project continuity.
- Owned interim and final contractual deliverables across assigned clinical projects and programs, balancing four delivery requirements: timeline, quality, scope, and cost.
- Oversaw clinical trial conduct, ensuring adherence to study protocols, SOPs, ICH/GCP, and regulatory requirements.
- Supported core sales-cycle workstreams as client-facing operational consultant: feasibility assessments, proposal development, budget management, client consultations, and operational RFP leadership.
Associate Project Manager
ICON plc
Blue Bell, PA
09.2023 - 12.2024
- Coordinated cross-functional teams and facilitated communication with clients to address needs and ensure alignment on project goals.
- Managed risk identification, mitigation, resolution, and escalation while ensuring compliance with ICH/GCP, local regulations, and ICON procedures.
- Executed daily project management activities, ensuring delivery met contractual, timeline, quality, scope, and cost standards.
Senior Project Associate
ICON plc
Lenexa, KS
10.2022 - 09.2023
- Managed six document-quality and inspection-readiness activities: TMF reconciliation, readiness reviews, archiving preparation, training reports, CV reports, and eTMF technical support to ensure compliance and preparedness.
- Acted as TMF gatekeeper and primary document management contact for TMF planning, setup, maintenance, and final shipment.
- Coordinated client and project team meetings, preparing agendas, minutes, presentations, correspondence, study plans, reports, and timelines to enhance communication and project alignment.
- Facilitated clinical project execution from contract through final delivery, ensuring creation and collection of study-specific documentation.
Project Associate I, EDS
ICON plc / PRA Health Sciences
Lenexa, KS
11.2020 - 10.2022
- Coordinated administrative and operational support for Project Management and Operations teams, managing scheduling, correspondence, agendas, minutes, meeting materials, and document distribution to ensure smooth project execution.
- Maintained accurate electronic study files, generated training and CV reports, and conducted readiness reviews to facilitate compliance and project readiness.
- Provided eTMF training and technical support and served as gatekeeper for TMF setup, maintenance, and final shipment.
- Supported RPSM and study setup by collecting and organizing study-specific documents, contributing to efficient project initiation.
Clinical Research Coordinator
Synexus
Evansville, IN
08.2017 - 05.2018
- Coordinated daily clinical research activities to ensure compliance with corporate requirements and approved study protocols, facilitating smooth study execution.
- Maintained sponsor communication while managing case report forms, informed consent, source documentation, study medications, clinical data collection, and training to support study integrity.
- Coordinated patient visits and study schedules at Synexus clinical research site.
- Obtained informed consent and explained study procedures to participants.
- Collected source documents and entered data into trial management systems.
Operations Coordinator
Covance Clinical Research Unit
Evansville, IN
01.2017 - 08.2017
- Coordinated clinical trial activities, ensuring adherence to protocols and maintaining study logistics for quality and accuracy.
- Coordinated clinical trial visits within Covance Clinical Research Unit schedules
- Managed study supplies, lab materials, and room readiness for participant appointments
- Processed source documents and maintained accurate clinical research records
- Trained ancillary staff and developed source documentation and study instructions while safeguarding client and participant confidentiality.
Research Technician & Site Trainer
Covance Clinical Research Unit
Evansville, IN
03.2013 - 01.2017
- Trained clinical operations staff and new hires on SOPs and sponsor-required study procedures to enhance operational consistency and adherence.
- Executed clinical trial procedures and administrative duties to ensure compliance with protocols and regulatory requirements for clinical pharmacology.
- Acted as a resource for site processes, conducted quality control of source documents and case report forms, and ensured accurate recording of clinical research data.
Education
Associate of Arts - Paramedic Science
Ivy Tech Community College
Evansville, IN11-2009
Skills
- Clinical Trial Management
- ICH/GCP & Regulatory Compliance
- Trial Master File (TMF/eTMF)
- Study lifecycle management
- Risk & Issue Mitigation
- Budget feasibility analysis
- Budget control
- Scope control
- Resource allocation
- Vendor management
- Schedule management
- Deliverable tracking
- Milestone tracking
- Cross-Functional Team Leadership
- Team leadership
- Cross-functional collaboration
- Project scope
- Workflow planning
- Project development
- Project closure
- Client communication management
- Stakeholder engagement
- Communication skills
- Problem solving
- Root-cause analysis
- Turnaround strategies
- Milestone tracking
LANGUAGE
English: High proficiency in conversation, reading, writing, and medical records/terminology.
Accomplishments
- Brings more than 10 years of progressive clinical research and clinical operations experience across project management, study coordination, operations, and site training roles.
- Advanced through three progressively responsible ICON / PRA Health Sciences positions from Project Associate I to Associate Project Manager between November 2020 and December 2024.
- Provides end-to-end study support spanning contract handoff, study setup, execution, TMF reconciliation, inspection readiness, archiving preparation, and final delivery.
- Built working expertise across three named eTMF platforms: PhlexEview, Veeva Vault, and Wingspan ICOMaster.
SYSTEMS & VENDOR EXPERIENCE
- TMF / eTMF Systems: PhlexEview eTMF; Veeva Vault eTMF; Wingspan eTMF (ICOMaster)
- Bioanalytical/Safety Lab Services: Aliri Bioa Lab, Fortrea, Quest Diagnostics, PPD
Timeline
Project Manager
ICON plc
12.2024 - 08.2026
Associate Project Manager
ICON plc
09.2023 - 12.2024
Senior Project Associate
ICON plc
10.2022 - 09.2023
Project Associate I, EDS
ICON plc / PRA Health Sciences
11.2020 - 10.2022
Clinical Research Coordinator
Synexus
08.2017 - 05.2018
Operations Coordinator
Covance Clinical Research Unit
01.2017 - 08.2017
Research Technician & Site Trainer
Covance Clinical Research Unit
03.2013 - 01.2017
Associate of Arts - Paramedic Science
Ivy Tech Community College