A highly motivated, detail-oriented, and results-driven professional with over 15 years of experience in the pharmaceutical industry. I am a self-starter, able to work well independently and as a team player.
management, records management, compliance
archiving, sops, laboratory, compliance
Ensured compliance with all applicable federal and state regulations and requirements. Developed and implemented a new system for the company.
Created and implemented a system for data management and billing, including creating and implementing a new system for the creation of a web-based application.
Created and implemented a comprehensive training program for the project managers, data managers, and other analysts. Provided support to the project team.
Managed and maintained project timelines and milestones, including data collection, data management, and reporting of results. Developed and implemented a comprehensive and efficient system for the study.
Managed the data entry team for the entire operations department and the Defense bank system (a.M., A.
Created and implemented a system for the creation of a web-based training program for the data management department.
United States Navy
Implemented and maintained a tracking system for archiving and retrieval of all pertinent documents. Developed and implemented SOPs for the company.
Performed all duties in compliance with the laboratory policies and procedures. Assisted in the preparation of reports for the department.
Assisted in the development and implementation of the quality assurance program. Performed all aspects of the management of the project.
Perform all aspects of the clinical operations management program (e.K.M.T.), and the coordination of the quality assurance and improvement activities.
Performed data entry, query resolution, and database management for multiple projects. Managed the preparation of study documents for submission to the FDA.
Reviewed and approved all regulatory documents for submission to the FDA. Developed and maintained a comprehensive and detailed tracking system for the clinical research.