https://innovation.cms.gov/initiatives/comprehensive-esrd-care/

Managed clinical trial, data management activities for Biometrics Department. Managed in-house database design and integrity for local and global clinical trials.Motivated and challenged staff to step outside comfort zones and become involved internally and externally on local, global, and cross-functional levels, thereby resulting in data management teams working exceptionally and with minimal supervision.Increased efficiencies and achieved faster timelines by encouraging staff to work smarter based on supporting process issues within study areas and embracing organizational initiatives, such as Optimizing Data Value (ODV) and single data collection.Championed alignment of laboratory reference-range processes across merged organizations, Genentech and Roche.

Led data management team activities, supporting clinical development in harmony with company criteria and GCP / ICH quality standards and regulations.

Managed all aspects of clinical trials for infectious disease immunoassays in US and Europe. Wrote clinical trial protocols (pre-IDE, PMA, 510K) in collaboration with Regulatory Affairs, Research and Development, Manufacturing, and Marketing.Collaborated and trained investigators at clinical sites in US, Germany, and Spain, maintaining compliance for hepatitis immunoassay clinical trials. Achieved completion of clinical trials of hepatitis B (e) antigen and antibody immunoassays from FDA submission through global product launch.Supervised clinical research associates, overseeing training and career development in direct support of clinical trials.

Oversaw multi-site data management activities for behavioral and mental health research studies sponsored by National Institutes of Drug Abuse (NIDA) and National Institutes of Mental Health (NIMH). Performed data management training, monitoring, data cleanup, report development, and data closeout processes.

Supervised operations of oncology clinical trials for cooperative, government-sponsored, and pharmaceutical industry studies. Staff of data managers, regulatory coordinators, adverse event monitors, and research nurses. Established, hired, and trained staff for new Adverse Event Monitor role.Aided in budget negotiations and increased traceability of revenue by developing budget template for pharmaceutical-sponsored trials.

Managed multi-site clinical trials in translational research setting that included protocol development, regulatory compliance, IRB and FDA submissions, patient recruitment, study conduct, study closeout, and data management.Obtained FDA approval (IND with CBER and CDER) of phase 0 and phase I clinical trials for dendritic cell vaccine for melanoma and HIV.

Coordinated several research teams, aiding in project administration, providing strategic management of research activities, data collection and analysis, and assisting with grant application preparations. Trained data managers in all participating sites in data collection processes. Developed data collection tools for 2 major projects (carotid endarterectomy and breast cancer).