Stephanie Lally

Strategic Clinical Research Executive with over 20 years of experience directing Phase I-IV operations and supervising cross-functional teams of up to 100+ personnel. Deep subject matter expertise in Oncology, Cardiology, and CNS therapeutic areas. Expert in GCP/ICH compliance, regulatory governance, and multi-site global operations.

Proven track record in scaling clinical infrastructure, negotiating multi-million-dollar contracts, and building high-performing project teams that consistently exceed enrollment and business goals.

Principal Consultant / Operations Advisor at Amicis Clinical Trials (2026-01 – Present)

• Provide high-level operational oversight and strategic consulting for multi-therapeutic clinical trials, ensuring long-term sustainability and regulatory excellence.
• Review and optimize study protocols to ensure operational feasibility and alignment with evolving FDA and ICH guidelines.
• Maintain and leverage a vast network of Sponsors, CROs, and clinical sites to facilitate high-impact research partnerships over a 17+ year tenure.

Senior Associate at Aptive Resources (2022-01 – 2024-12)

• Provided enterprise-level support to VA Investigators, streamlining research workflows to allow for enhanced focus on clinical care for Veterans.
• Consolidated fragmented study documentation into a standardized Operating Procedure (SOP) manual, improving site-wide efficiency and compliance.
• Engineered and managed study-specific databases using REDCap and SharePoint, ensuring high data integrity and centralized information access for multi-site teams.
• Spearheaded proposal development for clinical trials and administrative services, securing resources for critical research project management.

Director of Clinical Research / Director of Operations for Oncology at Innovative Research Network (2020-01 – 2022-12)

• Directed the operational lifecycle of global oncology programs, managing sub-site expansion and providing strategic guidance to domestic and international clinical staff.
• Ensured 100% compliance with international GCP guidelines and federal safety standards for all active oncology protocols.
• Negotiated complex study budgets and managed external contracts to ensure project profitability and fiscal sustainability.
• Authored and edited high-level Oncology Protocols, translating scientific objectives into executable, site-level operational plans.

CEO / Clinical Research Consultant at Professional Research Consultants, LLC (2016-01 – 2020-12)

• Consulted for physicians and medical staff on clinical drug development processes, study design, and comprehensive site monitoring strategies.
• Developed and delivered specialized training programs focusing on US FDA CFR compliance, elevating operational standards for client organizations.
• Fostered cross-functional collaboration to resolve complex operational bottlenecks in rapidly changing therapeutic environments.

Clinical Research Director for Cardiology at St. Louis Heart and Vascular (2014-01 – 2016-12)

• Managed and mentored a department of 50+ employees, overseeing the planning and execution of a robust Cardiology research program.
• Proactively identified and resolved clinical project issues, implementing process improvement initiatives that reduced study startup timelines.
• Built and maintained strategic partnerships with Sponsors, CROs, and CRAs to secure high-priority cardiovascular trials.
• Coordinated quality assurance activities and audit-finding resolutions, maintaining audit-ready documentation for all clinical files and patient records.

Director of Operations / Site Director for CNS at St. Louis Clinical Trials, LC (2011-01 – 2014-12)

• Led a workforce of over 100 office employees, executing business plans for the strategic and tactical goals of the CNS line of business.
• Designed and implemented a sales and marketing plan that cultivated new relationships with clinical trial sponsors and increased site revenue.
• Maintained all SOPs and training programs for subject recruitment, informed consent, and regulatory affairs, ensuring 100% adherence to GCP and FDA guidelines.
• Created and launched a comprehensive Quality Assurance program for all research activities, significantly improving data accuracy and CRF completion rates.

Clinic Manager for General Medicine at Radiant Research, Inc. (2007-01 – 2011-12)

Research Coordinator for General Medicine at Radiant Research, Inc. (2006-01 – 2007-12)

Research Coordinator for Gastroenterology at Washington University (2000-01 – 2006-12)

Master of Business Administration (MBA) – Lindenwood University

Bachelor of Science in Business Administration (BSBA) – Lindenwood University