Maria Maldonado
Director of Clinical Operations
[email protected] @LinkedIn Miami, FL
Summary
Highly experienced Director of Clinical Operations with over 10 years in clinical operations management within the pharmaceutical and biotechnology industries. Proven track record in managing clinical trials across all phases (Phase I-III) with expertise in operational strategies, cross-functional collaboration, and vendor management. Adept at ensuring compliance with regulatory requirements and achieving timely, on-budget trial completion while maintaining the highest quality standards.
Experience
Director, Clinical Operations
Glycomine, Miami, FL
May 2018 – Present
- Lead and oversee strategic planning and execution of clinical trials, ensuring alignment with project timelines, budgets, and quality standards. Successfully managed 15+ clinical trials, consistently meeting or exceeding milestones.
- Reduce trial costs by 20% through efficient budget management and risk mitigation.
- Facilitate cross-functional collaboration, resulting in a 30% improvement in project completion time.
- Provide operational expertise and strategic input into Clinical Development Plans (CDP). Contributed to the development of 10+ CDPs, enhancing operational feasibility and efficiency.
- Improve vendor performance by 25% through diligent oversight and strategic partnerships.
- Ensure compliance with regulatory requirements, ICH-GCP guidelines, and company SOPs. Maintained a 100% compliance rate across all clinical trials.
Senior Manager, Clinical Operations
BioPharma Solutions, Miami, FL
January 2015 – April 2018
- Managed clinical trials from start-up through close-out, ensuring timely and on-budget deliverables. Successfully completed 12 clinical trials, achieving a 95% on-time and on-budget delivery rate.
- Coordinated with internal and external stakeholders to support clinical trial deliverables. Improved stakeholder satisfaction scores by 20% through effective coordination and communication.
- Developed and implemented risk management strategies for clinical operations. Reduced operational risks by 30% through proactive risk management.
Education
Master of Science in Biological Sciences
University of Miami, Miami, FL
Graduated: May 2010
Bachelor of Science in Nursing
Florida International University, Miami, FL
Graduated: May 2007
Certifications
- Certified Clinical Research Professional (CCRP)
- Project Management Professional (PMP)
Skills
- Clinical trial management
- Regulatory compliance
- Vendor management
- Risk management
- Budgeting and financial oversight
- Cross-functional collaboration
- Data analysis and interpretation
- Excellent communication and interpersonal skills
Languages
- English (Native)
- Spanish (Fluent)