Brandi Carmona

Provide strategic leadership for North America study start-up and maintenance, ensuring delivery of client milestones on time, within budget, and driving continuous improvement in start-up efficiency.

Accelerated study startup protocols and achieved an 80%+ say/do ratio in projections by implementing lessons learned, improving system reliability and optimizing team resource allocation across North America.

Managed site activation and document workflows to deliver on-time, high-quality study startups across North America while maintaining regulatory compliance and improving milestone adherence.

Directed site start-up activities by developing and implementing structured workflows that improved efficiency and adherence to timelines for research startup across North America.

Developed study-specific GSS plans and managed regulatory and investigator documentation to ensure compliance with SOPs and local/international requirements.

Reviewed and approved core and site-specific patient-informed consents and liaised with operational teams to resolve project issues and secure international regulatory compliance.

Led recruitment and admissions operations managing a 19-person team, optimizing enrollment procedures and advertising budget to ensure on-time participant dosing and protocol compliance.

Completed a Master of Science in Clinical Research Organization and Management focusing on clinical trial operations and regulatory compliance.

Completed a Bachelor of Science in Business Management with coursework in business and management fundamentals.

Completed the Mid-Level Leader Excellence Program through Harvard Publishing Corporate Learning.