Social Work-Oriented Regulatory Leader in Healthcare

AIMEE M. CARPENTER

Tullahoma, ***** TN +1-615-***-**** ************@*****.*** linkedin.com/in/aimeecarpenterma Professional Summary

Senior Regulatory Affairs professional with 20+ years experience in global study start-up, site activation, regulatory oversight, and cross-functional leadership across Phase I-IV trials. Skilled in accelerating timelines, improving compliance, mentoring teams, and optimizing workflows while ensuring adherence to GCP, ICH, SOPs, and sponsor requirements. Proven record of leading remote teams to deliver high-quality outcomes across multiple therapeutic areas. Core Competencies

● Global Site Activation

● Clinical Trial Management

● Study Start-Up Optimization

● Regulatory Document Oversight

● Process Redesign

● Cross-Functional Leadership

● Risk and Quality Management

● Stakeholder & Sponsor Alignment

Professional Experience

Site Activation Lead / Project Manager 04/2022 to 11/2024 ICON PLC

● Drove activation across 120+ regional sites, accelerating launch timelines by 18 percent through workflow refinement and cross-functional coordination.

● Enhanced document approval precision by 22 percent by coaching teams on regulatory, IRB, and sponsor expectations.

● Strengthened site readiness by 30 percent by building targeted readiness assessments and training frameworks.

● Augmented audit-ready documentation from 85 percent to 98 percent by enforcing KPI monitoring and compliance standards.

● Cut activation turnaround times by 25 percent by restructuring escalation, routing, and tracking models. Start-Up Team Manager / Project Manager 10/2021 to 03/2022 PPD (Thermo Fisher Scientific)

● Shortened onboarding timelines by 20 percent for 40 associates through standardized training pathways.

● Boosted start-up consistency by 28 percent by building execution processes mapped to regulatory deliverables.

● Minimized financial discrepancies by 15 percent by reinforcing contract oversight and effective budget checks.

● Raised compliance from 82 percent to 95 percent by aligning workflows to data-driven performance insights.

Senior Study Start-Up Associate (Regulatory) 01/2021 to 10/2021 ICON PLC

● Mentored 12 associates, lifting documentation accuracy by 26% through tailored regulatory guidance.

● Achieved 96% first-pass approval rate for 60+ sites by preparing and coordinating submission packages.

● Streamlined document cycle times by 18% via optimized templates and approval workflows.

● Minimized sponsor rework requests by 22% through effective communication and QA oversight. Study Start-Up Associate II (Regulatory) 07/2019 to 12/2020 ICON PLC

● Oversaw submissions for 50+ sites, maintaining 95 percent on-time approvals through structured planning.

● Elevated document quality by 21 percent by integrating tiered QC and review safeguards.

● Accelerated internal routing efficiency by 14 percent through template optimization and workflow adjustments.

Clinical Research Services Consultant II (Project Manager) 12/2018 to 07/2019 Vanderbilt University Medical Center Nashville TN

● Directed 20 protocols and heightened milestone delivery precision by 17 percent through coordinated oversight.

● Enhanced onboarding proficiency by 25 percent with focused training on regulatory and operational procedures.

● Closed documentation gaps from 14 percent to 4 percent by standardizing QA checks and verification cycles. Study Start-Up Associate I (Regulatory) 09/2016 to 12/2018 ICON PLC Brentwood TN

● Delivered 95 percent on-time submissions by preparing tailored regulatory packages across multiple indications.

● Improved sponsor communication flow by 19 percent through streamlined request-response cycles. Translational Research Coordinator 03/2016 to 09/2016 Vanderbilt University Medical Center Nashville TN

● Increased protocol compliance by 18 percent by managing samples, consent, and visit workflows for 400 participants.

Education

Master of Arts: Psychology (Mediation & Conflict Resolution) University of The Rockies Colorado Spings, CO

Bachelor of Arts: Social Science

Ashford University Clinton, IA

Associate of Arts & Science: Applied Studies & Animal Health Technology San #HRJ#d5815940-9aae-Diego 41d9-80e1-ac0379efe03c# Mesa College San Diego, CA

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