ALLEN WATTS
Florence
Summary
Clinical Operations leader with 13+ years of progressive experience managing clinical trial delivery, developing high-performing clinical teams, and driving operational excellence across global Phase II-IV studies. Proven success leading cross-functional teams, mentoring Clinical Research Associates, optimizing study performance metrics, and delivering complex clinical programs on time and in compliance with ICH-GCP and regulatory requirements. Recognized for fostering collaboration, improving operational efficiency, and building strong sponsor and stakeholder relationships in dynamic CRO environments.
Overview
8
8
years of professional experience
Work History
Principal Clinical Research Associate
ICON
04.2025 - Current
- Improved study execution efficiency across multiple Phase III and IV trials as measured by on-time milestone delivery by leading Clinical Trial Management activities, proactively identifying operational risks, and driving resolution plans with study stakeholders.
- Enhanced monitoring quality and compliance as measured by reduced protocol deviations and inspection-ready documentation by conducting monitoring oversight, reviewing monitoring visit reports, and coaching CRAs on best practices.
- Strengthened team capability as measured by improved CRA performance and consistency by mentoring junior CRAs, facilitating co-monitoring visits, and providing ongoing operational guidance.
- Improved study readiness and operational consistency across participating sites as measured by successful implementation of study procedures by developing and delivering operational guideline training at a national Investigator Meeting attended by more than 200 Principal Investigators, site leaders, sponsor Clinical Operations staff, Medical Monitors, and cross-functional stakeholders.
- Improved operational oversight as measured by study performance metrics, enrollment trends, monitoring compliance, and milestone achievement by proactively reviewing trial data and implementing corrective actions when needed.
- Improved cross-functional collaboration as measured by faster issue resolution and improved stakeholder satisfaction by serving as a central operational liaison between CRAs, sponsors, data management teams, regulatory teams, and project leadership.
- Increased cross-functional alignment as measured by faster issue resolution and stakeholder satisfaction by partnering with Clinical Operations, Data Management, Regulatory Affairs, Medical Monitoring, and Project Leadership teams to drive study delivery and operational excellence.
- Maintained Trial Master File (TMF) inspection readiness as measured by audit readiness and document quality by overseeing essential documentation and ensuring compliance with ICH-GCP, sponsor requirements, and study procedures.
- Supported Vendor Management and operational oversight activities as measured by adherence to study timelines and quality expectations by collaborating with CRO partners, sponsors, and study teams to proactively address operational challenges.
Lead Clinical Research Associate / Senior Clinical Research Associate
IQVIA
01.2022 - 04.2025
- Improved operational delivery across two rare disease clinical trials as measured by achievement of enrollment targets by leading study execution, optimizing site engagement strategies, and coordinating activities across 25 sites.
- Developed a high-performing team of 10–15 Clinical Research Associates as measured by study quality metrics and sponsor satisfaction by implementing structured coaching, training programs, and performance development plans.
- Enhanced study start-up performance as measured by accelerated site activation timelines by leading investigator meetings, site initiation activities, and protocol training programs.
- Strengthened sponsor relationships as measured by repeat assignments and leadership recognition by serving as the primary liaison between sponsor leadership and clinical operations teams.
- Improved monitoring oversight as measured by data quality and compliance outcomes by reviewing monitoring reports, identifying trends, and implementing corrective actions.
- Supported Vendor Management and CRO oversight activities as measured by adherence to study timelines and deliverables by collaborating closely with sponsors, vendors, and functional teams.
- Contributed to Budget Management efforts as measured by accurate site financial tracking and resource allocation by coordinating study activities and monitoring operational expenditures.
Clinical Research Associate
IQVIA
11.2020 - 03.2023
- Improved site performance as measured by enrollment, data quality, and regulatory compliance by conducting qualification, initiation, monitoring, and close-out visits across multiple clinical sites.
- Maintained Trial Master File (TMF) quality and inspection readiness as measured by successful audits and sponsor reviews by ensuring completeness and accuracy of study documentation.
- Enhanced study execution as measured by adherence to timelines and milestone completion by proactively managing site risks, enrollment challenges, and data queries.
- Strengthened stakeholder engagement as measured by site retention and performance by building collaborative relationships with investigators and site staff.
Clinical Project Manager
Cincinnati Children’s Hospital Medical Center
02.2018 - 11.2020
- Improved operational efficiency across 80+ sites as measured by data completeness and reporting accuracy by implementing standardized workflows, tracking systems, and quality controls.
- Coordinated investigators, sponsors, data management teams, and site personnel to enhance cross-functional collaboration and ensure timely completion of study deliverables.
- Accelerated study start-up activities as measured by reduced activation timelines by supporting protocol development, regulatory submissions, and site onboarding processes.
- Led project planning and operational execution initiatives to strengthen organizational performance, resulting in successful annual reporting and improved stakeholder satisfaction.
Education
Bachelor of Science - Information Technology
Capella University
Minneapolis, MN03-2020
Medical Assistant Certification -
Lincoln College of Technology
Florence03-2011
Skills
- Clinical Operations Management
- Clinical Trial Management
- Team Leadership
- Staff Development
- Cross-Functional Leadership
- Vendor Management
- CRO Oversight
- Budget Management
- Monitoring Oversight
- Site Management
- Performance Metrics
- Risk Management
- Process Improvement
- Trial Master File (TMF)
- Inspection Readiness
- Study Start-Up
- Enrollment Strategy
- Database Lock
- Study Close-Out
- ICH-GCP
- FDA Regulations
- CTMS: Veeva Vault Clinical
- Siebel Clinical
- EDC: Medidata RAVE
- REDCap
- ETMF: Veeva Vault eTMF
- IRT: Almac
- Calyx
- ECOA/ePRO: Clario
- Analytics: Power BI
- SAS
- Microsoft Excel
- Clinical trial management
- Site management
- Data monitoring
- Stakeholder engagement
Clinical Systems
Veeva Vault Clinical, Siebel Clinical, Medidata RAVE, REDCap, Veeva Vault eTMF, Almac, Calyx, Clario, Power BI, SAS, Microsoft Excel
Leadership Experience
- Led and developed teams of up to 35 Clinical Research Associates across rare disease and vaccine programs.
- Mentored newly hired CRAs through onboarding, training, co-monitoring visits, and performance coaching.
- Facilitated team development sessions focused on monitoring quality, protocol compliance, and operational best practices.
- Supported talent development initiatives that improved team consistency, study execution, and sponsor satisfaction.
Timeline
Principal Clinical Research Associate
ICON
04.2025 - Current
Lead Clinical Research Associate / Senior Clinical Research Associate
IQVIA
01.2022 - 04.2025
Clinical Research Associate
IQVIA
11.2020 - 03.2023
Clinical Project Manager
Cincinnati Children’s Hospital Medical Center
02.2018 - 11.2020
Bachelor of Science - Information Technology
Capella University
Medical Assistant Certification -
Lincoln College of Technology