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BackgroundSeri Gomberg has a unique combination of experience in management, clinical trials and computer programming. Her focus is on efficient and effective processes, in a productive atmosphere. She is both highly analytical and very social, a rare combination. Add to that her flexibility and creativity, and you can understand why she has never followed a normal career path.Ms. Gomberg received her bachelor's degree in Biology, with a minor in Math and Computer science, and her masters in Biochemistry from the Hebrew University in Jerusalem. In 1994 she started working in the clinical trials arena performing a variety of tasks, including trial design and implementation, software development, and research management. At the University of California, San Francisco, Ms. Gomberg was promoted to managing the Breast Care Center Clinical Research Unit. In 1998 she started working with device startups on creating and implementing ICH-GCP-compliant studies. She easily collaborated with software developers and facilitated their work. Learning their vocabulary quickly, and understanding their constraints, Ms. Gomberg provided feedback from the operations front to the software development process. The result was a more user-friendly product with a minimum of costly software changes. Following this experience, Ms. Gomberg sought out clinical software applications and started writing clinical trial modules for iKnowmed, an Electronic Medical Record for oncology practices. Ms. Gomberg became the point person for clinical trials, coordinating the technical aspects of the clinical trials efforts. She was on the team that wrote the first demonstrated CDISC document to export clinical research data from an Electronic Medical Record. In that effort she gained an understanding of the core technology, and the impact of 21 CFR 11 compliance on the development efforts. Ms. Gomberg then managed a research team in an epidemiologic study. When she arrived, she analyzed both the procedures and the workforce. She initiated and led an effort to formally define current operations, and improve efficiency, employee satisfaction, and cost-effectiveness. She revised a major process, and implemented a re-structuring of the process and workforce. By re-distributing some tasks and successfully outsourcing others, she reduced expenses by 50%, while increasing productivity and quality control. Ms. Gomberg was a member of the senior management team, and worked with this team to address a variety of issues. Professional Philosophy/VisionIf Ms. Gomberg had to limit her professional philosophy to one word, it would be integrity. Luckily, she is not limited in space here, so she can elaborate. The following are some lessons she has learned and used effectively during her career.
Communication
The role of Technology in Business Technological tools can be designed and modified to better fit processes and work flow, and work flow and processes can be designed and modified to utilize existing technology. At the intersection of these concepts lay the right balance between user education and product modification. Ms. Gomberg participated heavily in this process at Karmel Medical Acoustic Technologies and at iKnowMed.
Systems
Perfect solutions are rare. Efficiency and effectiveness work hand-in-hand to provide a good balance between a project's time to completion, quality and cost. Success StoriesMs. Gomberg was hired to coordinate the submission of a large ($2.5M/year) grant proposal at the University of California, San Francisco. She had 2 months until the deadline. The grant application had 15 parts, some of them financially complex. The rules governing this special type of grant and the people involved were new to her. She learned all about the organization and the grant, using internal and external resources as appropriate. She did not limit herself to the way things had been done before (such as performing the photocopying in house) and succeeded in submitting 20 copies of the 520-page document on time to the University authorities and to the National Cancer Institute. The grant was awarded and provided 5 years of funding.At Karmel Medical Ms. Gomberg's part-time employees performed manual analysis of sound files. Frequently they had to wait for specific employees to complete an analysis. A system was needed to allow one employee to pick up where the others left off and to make sure the analysis was performed uniformly. Three of the employees were new hires. One of the new employees was assigned to write up procedures as she received training. The experienced employees were asked to review the procedures, and the other new employees were instructed to follow the procedure step-by-step. A rigorous description of the process resulted. This allowed consistency, as well as continuity in the work between employees. Obviously, this decreased the elapsed time to performing complete analyses, and improved their ability to meet deadlines. The added benefit was a rigorous description of the analysis available for publication. It also allowed a basis for performing quality control. Ms. Gomberg was asked to manage a large ongoing survey study with 7 field interviewers at University of California, Berkeley. There was a back-log of 100 interviews that had not yet been scheduled, some of them going back more than 6 months. Ms. Gomberg asked for a report of the interviews completed per interviewer per month going back to the beginning of the study (5 years). The patterns of productivity were erratic. Ms. Gomberg interviewed interviewers who seemed to have consistently low productivity, discussed their challenges, and clarified her expectations. Then she explained the productivity targets to the group. When these measures improved productivity only incrementally, Ms. Gomberg consulted with the survey research unit on campus, and implemented centralized scheduling. They took advantage of the economy of scale resulting from a larger calling volume (100 calls from the office, vs. 12 calls per interviewer), and identify when a specific employee's work schedule was interfering with his/her ability to perform the required interviews. She then talked with the employee in question and came to an agreement about how the problem would be rectified. As a result all the outstanding interviews were performed, as well as additional interviews that were added during the transition period, within about 10 man months. Career GoalsMs. Gomberg's long term goal is to help businesses improve by analyzing them, and then working with employees and management to make processes more efficient, assign tasks to employees who will enjoy them, and therefore perform them promptly and well, and make sure employees are not engaged in a majority of tasks which they resent performing.Seri is used to working on the cutting edge, and by charting her own path and working independently she believes she provides a truely custom and revolutionary approach, leading to extraordinary value for her clients. . ReferencesReferences available online from iKnowMed and University of California, Berkley. Additional references available upon request.
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