CV / English / Clinical Study Manager
Jessica Miller
123 Health Way, Scienceville, CA 98765 Phone: (555) 123-4567 Email: [email protected]
Brief
A detail-oriented and strategically-minded Clinical Study Manager with over 8 years of experience in the pharmaceutical industry. Expert in planning, executing, and leading clinical trials with a sharp focus on ensuring adherence to protocols, regulatory compliance, and achieving objectives within time and budget constraints. A proactive leader with a strong capacity for driving teams towards excellence in clinical research.
Core Competencies
- Clinical Trial Management
- Regulatory Compliance
- Team Leadership & Coordination
- Study Design & Protocol Development
- Budget Oversight & Resource Allocation
- Cross-functional Collaboration
- Risk Management
- Data Integrity & Patient Safety
Technologies and Certifications
- Proficient in Clinical Trial Management Systems (CTMS)
- Advanced user of Electronic Data Capture (EDC) systems
- Certified Clinical Research Associate (CCRA)
- Good Clinical Practice (GCP) Certified
- Knowledgeable in SQL and data analysis tools for research data interpretation
Professional Experience
Senior Clinical Study Manager – PharmaCorp Inc., Scienceville, CA
March 2018 – Present - Led a cross-functional team of 20+ members in the execution of Phase 3 clinical trials for a novel cardiovascular drug, managing a budget of $2M. - Achieved patient enrollment targets 3 months ahead of schedule, enhancing study feasibility and reducing timeline by 15%. - Ensured 100% audit readiness, resulting in zero critical findings during regulatory audits.
Clinical Study Coordinator – BestHealth Pharma, Scienceville, CA
June 2015 – February 2018 - Coordinated day-to-day operational aspects of several clinical studies, including patient recruitment, data collection, and compliance. - Improved study protocol adherence by 25% through the implementation of a comprehensive training program for site investigators. - Facilitated effective communication between clinical teams, sponsors, and external vendors to ensure project milestones were met.
Education and Training
- Master of Science in Clinical Research, University of Scienceville, 2015
- Bachelor of Science in Biology, Health Science University, 2013
Continuing Education: - Advanced Clinical Project Management Workshop, 2019 - Leadership Skills for Scientists, 2017
Referees
Available upon request.