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Expertise
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Associate Experience
Project Management:
- 15+ years experience in leading and managing large multi-national clinical trials
Clinical Data Management
- 10+ years experience in performing database setup (>400 clinical studies), programming edit checks (>60,000), entering and cleaning data (>2 million CRF pages), and project oversight for >400 clinical studies
Biostatistics
- 16+ years experience in developing statistical strategies for clinical development plans, statistical methodology for clinical studies, and production of statistical summaries and corresponding analyses
- 10+ years experience in statistical programming providing analysis datasets, pooled datasets, statistical tables, figures, and listing for Phase I-IV clinical trials, Health Outcome studies, and submission ISS/ISE.
Medical Writing
- 8+ years experience authoring submission documents for a regulatory audience
Clinical Quality Assurance
- 20+ years experience in ensuring subject safety/protection of rights, regulatory compliance, and data integrity
Clinical Resourcing
- 10+ years industry experience servicing clinical clients nationwide, including single projects consisting of more than 50 contractors
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