I have extensive experience working with clinical trial protocols, ensuring compliance with regulatory requirements such as FDA, EMA, and ICH-GCP guidelines. My role involved reviewing protocols, preparing regulatory submissions, and maintaining documentation to ensure adherence to standards. I also collaborated with cross-functional teams to address compliance issues and implement corrective actions, ensuring trials were conducted ethically and efficiently.

I use project management tools like Microsoft Project and Smartsheet to create detailed timelines, set milestones, and monitor progress. Regular communication with stakeholders ensures alignment, and I proactively identify potential delays, implementing mitigation strategies to keep projects on track. My approach ensures timely completion of trial phases while maintaining quality and compliance.

I implement robust data management practices, including electronic data capture (EDC) systems, routine data audits, and validation checks. I also train team members on proper data entry and documentation procedures. By maintaining clear communication with data managers and investigators, I ensure discrepancies are resolved promptly, upholding data integrity throughout the trial lifecycle.

I address recruitment challenges by analyzing barriers, such as eligibility criteria or site accessibility, and collaborating with sites to develop targeted strategies. This includes leveraging patient databases, social media, and community outreach. I also monitor recruitment metrics and adjust strategies as needed to meet enrollment goals while maintaining ethical standards.

I have managed clinical trial budgets by developing detailed cost estimates, tracking expenses, and ensuring adherence to financial constraints. I work closely with finance teams to forecast costs, negotiate vendor contracts, and identify cost-saving opportunities. My focus is on optimizing resources while maintaining trial quality and compliance with sponsor requirements.