Ashley Padgett
Summary
Results-driven clinical operations professional with extensive experience in early-phase pharmaceutical research and global trial operations within CRO environments. Expertise in scope assessment, feasibility evaluation, and resource planning enhances strategic growth and study execution. Collaborates effectively with commercial and operational teams to deliver client-focused solutions, drive proposal development, and optimize operational strategies.
Overview
10
10
years of professional experience
Work History
Principal Operational Strategy Specialist
PPD, Part of Thermo Fisher Scientific
Austin, TX
04.2023 - Current
- Leverage Salesforce to validate project scope, optimize resource allocation, and analyze operational intelligence to support strategic planning and execution.
- Partner with Business Development teams to support clients through strategic calls, in-person meetings, and cross-functional collaboration.
- Advise clients on study design strategy, including geographic footprint, site selection approach, and operational trade-offs to optimize feasibility, timelines, and cost efficiency.
- Disseminate operational strategy to proposal teams, ensuring budget alignment with strategic goals and driving the development of operations segments in proposal deliverables within established timelines.
- Identify areas for efficiency improvement and implement process improvements to enhance efficiency and reduce costs, specifically bridging the gap between Salesforce and our operational CRM.
- Lead knowledge transfer from bid defense through post-award transition, ensuring continuity of strategy and supporting development of high-impact client presentation materials and proposal decks.
- Support development of commercial strategy for new site expansion into an emerging region, including creation of business development tools, scenario modeling, and cost frameworks to enable informed client discussions.
Senior Operational Strategy Specialist
PPD, Part of Thermo Fisher Scientific
Austin, Texas
02.2022 - 04.2023
- Led operations proposal development, ensuring timely alignment with strategic objectives.
- Converted commercial win strategies into operational approaches, boosting proposal success rates and driving growth.
- Collaborated with cross-functional teams to create project plans and timelines, enhancing project clarity and execution.
- Performed feasibility analysis on patient studies, identifying optimal solutions that addressed client needs.
- Provided insights on protocol design, enhancing patient safety, efficacy outcomes, timeline adherence, budget control, and regulatory compliance.
- Maintained up-to-date global regulatory knowledge through continuous education and advanced training opportunities.
- Participated in executive triage calls for new opportunities, providing insights on operational strategy.
Clinical Research Coordinator
TKL Research, Inc.
Fair Lawn, NJ
01.2021 - 12.2021
- Executed study start-up procedures, ensuring timely IRB submissions and comprehensive regulatory binder management.
- Coordinated clinical trial activities for multiple research projects, facilitating seamless collaboration among stakeholders.
- Managed participant recruitment and enrollment, optimizing processes to enhance study completion rates.
- Monitored and reported adverse events, ensuring compliance with regulatory requirements.
- Proactively identified and mitigated risks to uphold study compliance and subject safety.
- Conducted training sessions for clinical nursing and lab staff, ensuring continuous monitoring and retraining.
- Collaborated with accounting to oversee budgets and invoicing, providing insights for change orders.
Clinical Research Coordinator/Medical Assistant
Dallas Center for Dermatology and Aesthetics
Dallas, TX
01.2020 - 12.2020
- Provided direct patient care, including medical history collection, vitals monitoring, phlebotomy, and assistance with exams.
- Screened and consented subjects for clinical trials, ensuring understanding and compliance with protocol.
- Managed study medication accountability and maintained temperature logs for storage facilities.
- Coordinated communications between sponsor and CRO personnel, facilitating project alignment and timely updates.
- Oversaw regulatory submissions and maintained regulatory binder compliance.
Clinical Research Coordinator
Pharmaceutical Product Development, LLC
Austin, TX
03.2019 - 12.2019
- Collaborated with principal investigator, sponsor, and research staff to plan, conduct, and evaluate project protocols.
- Identified and mitigated risks to ensure study compliance and safeguard subject safety.
- Reported and followed up on adverse events as per the protocol and regulations.
- Coordinated with vendors to facilitate study-specific procedures, ensuring adherence to protocol.
Clinical Research Recruiter
Pharmaceutical Product Development, LLC
Austin, TX
07.2018 - 03.2019
- Facilitated subject enrollment in clinical trials through targeted recruitment, informed consent, screening, and enrollment processes.
- Collaborated with physician and subjects to assess study design and ensure alignment with inclusion/exclusion criteria.
Graduate Research Assistant
Texas A&M University College of Veterinary Medicine
College Station, TX
05.2016 - 08.2018
- Used the pregnant sheep model in biomedical research to understand the maternal-fetal implications of opioids.
- Coordinated with doctors and undergraduate students to implement schedules for data collection, treatment administration, and lab organization.
- Supervised undergraduate students in the lab to ensure compliance with animal welfare and biosafety standards.
Education
Master of Science - Biomedical Science
Texas A&M University
College Station, TX08.2018
Bachelor of Science - Biomedical Science
Texas A&M University
College Station, TX05.2016
Skills
Awards
Outstanding Masters Student Award, Texas A&M College of Veterinary Medicine and Biomedical Sciences, 2018
Publications
- Padgett AL, Lepiz ML, Mackay EE, Driskill AJ, Ivanov IV, Fajt VR, Konarik MM, Mays TP, Washburn SE., Comparison of analgesic efficacy and fetal effects between transdermal administration of fentanyl and intramuscular administration of buprenorphine in pregnant sheep., Am J Vet Res., 07/01/20, 81, 7, 581-593, 10.2460/ajvr.81.7.581, 32584185
- MacKay EE, Washburn KE, Padgett AL, Fajt VR, Lo CP, Mays TP, Washburn SE., Pharmacokinetics of tulathromycin in fetal sheep and pregnant ewes., J Vet Pharmacol Ther., 07/01/19, 42, 4, 373-379, 10.1111/jvp.12744, 30656702
- Washburn KE, Fajt VR, Polasek AN, Lawhon SD, Padgett AL, Lo CP, Mays TP, Washburn SE., Oxytetracycline concentrations in interstitial fluid from tissue chambers inoculated with Corynebacterium pseudotuberculosis after intramuscular or intrachamber administration in sheep., Am J Vet Res., 06/01/19, 80, 6, 586-594, 10.2460/ajvr.80.6.586, 31140853
Presentations
- VTPP Graduate Student Summer Research Seminar, 2017
- CVM Graduate Student Research Symposium, 2017
- CVM Graduate Student Recruitment Day Flash Talk, 2017
- Interdisciplinary Faculty for Reproductive Biology Raymond O. Berry Research Seminar, 2017
Timeline
Principal Operational Strategy Specialist
PPD, Part of Thermo Fisher Scientific
04.2023 - Current
Senior Operational Strategy Specialist
PPD, Part of Thermo Fisher Scientific
02.2022 - 04.2023
Clinical Research Coordinator
TKL Research, Inc.
01.2021 - 12.2021
Clinical Research Coordinator/Medical Assistant
Dallas Center for Dermatology and Aesthetics
01.2020 - 12.2020
Clinical Research Coordinator
Pharmaceutical Product Development, LLC
03.2019 - 12.2019
Clinical Research Recruiter
Pharmaceutical Product Development, LLC
07.2018 - 03.2019
Graduate Research Assistant
Texas A&M University College of Veterinary Medicine
05.2016 - 08.2018
Master of Science - Biomedical Science
Texas A&M University
Bachelor of Science - Biomedical Science
Texas A&M University