David Prater
Summary
Operational excellence and clinical operations leader with 10+ years of experience driving global process improvement, vendor governance, and cross-functional transformation in regulated environments. Proven ability to optimize complex workflows, improve operational performance, and lead data-driven decision-making initiatives across clinical and digital ecosystems. Strong track record of implementing scalable solutions, enhancing quality, working with supply chain partners and compliance, and aligning global teams to deliver measurable business impact.
Overview
10
10
years of professional experience
1
1
Certification
Work History
Clinical Study Manager
Takeda Pharmaceuticals
12.2023 - Current
- Lead cross-functional global study operations, driving process standardization and execution consistency across complex clinical programs
- Identify operational inefficiencies and implement continuous improvement initiatives, improving study execution timelines and quality outcomes
- Develop and monitor key performance indicators (KPIs) to proactively manage study risks, vendor performance, and operational health
- Partner with clinical, data management, regulatory, and IT teams to optimize workflows and enhance system utilization (CTMS, eTMF, EDC)
- Drive inspection readiness and quality compliance, ensuring alignment with GCP and internal SOPs
- Influence stakeholders across functions to adopt improved processes, tools, and best practices
- Lead issue resolution and escalation management, ensuring rapid mitigation of risks impacting timelines or quality
- Developed and implemented project timelines, ensuring alignment with regulatory requirements.
- Negotiated contracts with vendors and service providers, securing competitive pricing while maintaining high-quality standards for all aspects of the study.
Project Manager II
Syneos Health
01.2022 - 01.2023
- Managed global clinical projects with a focus on operational efficiency, vendor performance, and delivery excellence
- Implemented structured risk management frameworks and reporting dashboards, improving visibility and decision-making
- Led vendor governance activities, ensuring adherence to contracts, KPIs, and quality standards
- Drove process improvements across study startup and execution phases, reducing operational friction
- Collaborated cross-functionally to align timelines, budgets, and operational deliverables
Project Manager – Oncology
Firma Clinical Research
01.2021 - 01.2022
- Directed oncology clinical programs with emphasis on process optimization and operational effectiveness
- Coordinated global vendor ecosystems, improving workflow integration and execution consistency
- Managed project timelines, budgets, and deliverables using data-driven insights
- Led process improvement initiatives to enhance study startup and site activation performance
- Implemented process improvements that enhanced operational efficiency and reduced project risks.
- Led cross-functional teams to ensure successful project delivery within timelines and budgets.
- Collaborated with clients to define project scope, objectives, and deliverable expectations effectively.
- Monitored progress against established goals, adjusting schedules and resources as needed to keep projects on track.
- Provided detailed project status updates to stakeholders and executive management.
Project Manager
PCM Clinical Trials
01.2021 - 01.2021
- Oversaw decentralized clinical trial programs, driving innovation in digital and remote study execution
- Managed technology vendors and logistics partners, ensuring operational alignment and efficiency
- Improved study delivery through process adjustments and performance monitoring
- Coordinated with cross-functional teams to resolve project issues and mitigate risks.
- Promoted innovation within project teams, encouraging exploration of new tools and methodologies to enhance project outcomes.
- Provided detailed project status updates to stakeholders and executive management.
Clinical Research Coordinator → Senior CRA
VA Medical Center | University of Colorado | University of Virginia
01.2016 - 01.2021
- Progressed into leadership roles managing clinical trials with increasing scope and complexity
- Ensured protocol adherence, data quality, and regulatory compliance across multiple studies
- Supported process standardization and operational improvements at the site and regional level
- Contributed to training and mentoring of research staff on best practices and compliance
- Coordinated clinical trial logistics, ensuring compliance with regulatory guidelines and protocols.
- Trained new staff on clinical trial procedures, fostering a culture of knowledge sharing and continuous improvement.
- Trained new team members on essential clinical research protocols and procedures, promoting a culture of continuous learning.
Education
Master of Biopsychology -
Northcentral University
12-2017
Bachelor of Liberal Arts & Sciences - Psychology
Rider University
05-2015
Skills
- Smartsheet, Jira, Asana, Mondaycom, MS Project, Excel, Power BI, Tableau
- CTMS, eTMF, EDC, eCOA, IWRS
- SharePoint, Confluence, Teams, OneDrive
- Adverse event reporting
- Clinical trial management
- Clinical data management
- Clinical research
- Data management
- Clinical operations
Websites
Certification
- GCP / ICH
- NIH Human Subjects Protection
- HIPAA
- IATA
CORE COMPETENCIES
- Operational Excellence & Continuous Improvement (Lean mindset)
- Process Optimization & Standardization
- Cross-Functional Leadership & Global Collaboration
- Clinical Operations & Study Execution
- Vendor & Supplier Governance
- KPI Development & Performance Monitoring
- Change Management & Transformation
- Risk Management & Quality Compliance (GxP, ICH-GCP)
- Data Analytics & Visualization (Power BI, Tableau)
- Digital Systems & Technology Enablement
Timeline
Clinical Study Manager
Takeda Pharmaceuticals
12.2023 - Current
Project Manager II
Syneos Health
01.2022 - 01.2023
Project Manager – Oncology
Firma Clinical Research
01.2021 - 01.2022
Project Manager
PCM Clinical Trials
01.2021 - 01.2021
Clinical Research Coordinator → Senior CRA
VA Medical Center | University of Colorado | University of Virginia
01.2016 - 01.2021
Master of Biopsychology -
Northcentral University
Bachelor of Liberal Arts & Sciences - Psychology
Rider University