Clinical Research Operations Manager Resume
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Professional Summary
Experienced Clinical Research Operations Manager with over 10 years of managing complex clinical trials from inception through completion. Proven track record of ensuring regulatory compliance, optimizing processes, and building high-performing teams. Adept at budget management, strategic planning, and facilitating cross-functional collaboration to achieve organizational objectives.
Core Competencies
Clinical Trial Management
Regulatory Compliance
Team Leadership
Budgeting and Financial Oversight
Risk Management and Mitigation
Data Analysis and Reporting
Process Optimization
Professional Experience
Clinical Research Operations Manager
Nextiven Pharmaceuticals, City, State
June 2057 - Present
Lead a team of 15+ clinical research professionals in the management of 25+ multisite clinical trials.
Develop and implement standardized procedures to improve trial efficiency, resulting in a 20% reduction in average study duration.
Ensure all trials are conducted in compliance with FDA regulations, ICH/GCP guidelines, and internal policies.
Oversee budget allocation and expenditure for research operations, successfully managing a $10 million annual budget.
Collaborate with cross-functional teams, including data management, biostatistics, and regulatory affairs to align on trial objectives and deliverables.
Clinical Research Associate
ClearFifty Clinical Research Group, City, State
May 2052 - May 2057
Monitored 50+ clinical sites for adherence to study protocols, regulatory compliance, and data integrity.
Trained and mentored junior staff members to enhance their skills in clinical trial management and monitoring activities.
Assisted in the preparation and review of trial documentation, including protocols, consent forms, and case report forms.
Liaised with investigators and site staff to address issues and ensure efficient trial progression.
Education
Master of Science in Clinical Research
University of Texas MD Anderson Cancer Center – Houston, TX
January 2052
Bachelor of Science in Biology
University of California, Los Angeles (UCLA) – Los Angeles, CA
May 2050
Certifications
Professional Affiliations
References
Available upon request.
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