Results-driven clinical operations leader with extensive experience in managing and optimizing clinical trials and research processes. Proven track record in enhancing operational efficiency, ensuring regulatory compliance, and fostering cross-functional collaboration. Skilled in budget management, team leadership, and strategic planning, with a strong focus on patient safety and data integrity. Adept at implementing best practices to streamline workflows and improve outcomes in fast-paced environments. Passionate about advancing clinical research and driving innovation in healthcare.

Experienced TMF professional specializing in the management and oversight of Trial Master Files (TMF) and Inspection Readiness to ensure compliance with regulatory requirements and industry standards. I have a proven track record in streamlining TMF processes, conducting quality reviews, and implementing best practices for document management throughout the clinical trial lifecycle. With expertise in electronic TMF systems, I facilitate training sessions and provide strategic guidance to clinical teams to enhance document integrity and accessibility.My background includes collaborating with cross-functional teams to develop TMF-related policies, ensuring timely document uploads, and preparing for audits and inspections. Committed to continuous improvement, I leverage my analytical skills to identify areas for optimization and contribute to the successful execution of clinical trials.

Oversee the implementation, maintenance, and optimization of clinical systems (i.e., eTMF, CTMS) and related processes in support of Reata’s global clinical trial programs in rare disease patient populations.

Responsible for the strategic planning, oversight and execution of study start-up, TMF operational expertise, and ensuring TMF completeness and accuracy in support of Reata’s clinical studies conducted in multiple geographic regions.

As a Senior Manager, I was responsible for leading cross-functional efforts to effectively and efficiently deliver on strategic recruitment and retention objectives in support of Reata's global clinical trials. To achieve this I managed and delivered high quality operational and project management support,

As part of the Program Management team, I was responsible for the design, implementation, assessment and measurement of strategies to promote collaborative relationships with clinical research sites participating in Reata's rare-disease research. My primary responsibilities included assessing recruitment support needs based on therapeutic indications, researching community and physician outreach opportunities, coordinating and implementing study awareness building activities with clinical research sites, and serving as the primary liaison for clinical research sites.

As part of the Clinical Ancillary team, I provided support and managed healthcare system implementations, installations, end-user testing and upgrades in multiple clinical applications that provide critical information for diagnosing and treating patients. These systems include Radiology Information Systems, RIS (including EPIC Radiant), Cardiovascular Information Systems, CVIS (including EPIC Cupid), Picture Archive and Communication Systems (PACS), Nuance Dragon(PowerScribe360), Mammography Information Systems (Magview) and many others that helped UTSW effectively provide high-quality care.

Project Manager for multiple Task Orders on the VA funded Gulf War Research Illness at UT Southwestern Medical Center's Program Management Organization.

Assistant Project Manager for International Clinical Research Patient Recruitment and Retention Programs.