Dynamic operations manager with experience in business management, clinical trials and computer
programming. Deep experience building consensus and advancing team efforts. Competent and
adaptable leader. Successfully communicates with people from many disciplines and cultures.
Core Competencies include:
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Professional Experience
Consultant (Self employed)
2003-Present
Provide fresh, creative analysis of business operations for clients in a variety of business endeavors. Support clients to make them more efficient and effective.
- Hired and trained Administrative Assistant for Landscaper. Developed job description, screened candidates, developed systems, and trained both Assistant and Landscaper.
- Screened assistants for organizational consultant.
- Tracked three construction projects to completion, performed accounts payable, purchasing, and more.
- Performed monthly website updates for various clients.
- Wrote and edited protocols for biotech & medical device companies.
- Taught adult education classes in computer skills. Developed and taught hobby classes in knitting.
- Managed accounts for cabinet maker, handled client communications.
Manager, Field Operations and Office Administration
Reference letter 2001-2003
University of California, Berkeley- Managed research program. Responsibility expanded progressively from 5 to 14 employees.
- Planned and implemented restructuring to improve quality, productivity and cost-effectiveness, resulting in a 50% reduction in expenses.
- Negotiated and managed outsourcing relationships, including specialized expertise in the project.
- Member of senior management team, providing leadership when needed.
Clinical Informatics Analyst
Reference letter 2000-2001
iKnowMed, Berkeley, California
- Managed implementation of screening for over 100 oncology clinical trials in Electronic Medical Record (EMR)
- Wrote one of first CDISC file to export records from database; wrote data collection program.
- Programmed clinical trial screening to review EMR and alert physician when a patient qualified for a study.
- Programmed detailed eligibility criteria to provide automated definitive determination of eligibility.
- Programmed capture of CRF data within patient chart and maintained program written by others.
Manager, Clinical Operations
1999-2000
Karmel Medical Acoustic Technologies, Yokneam Illit, Israel (Device Start-up)
- Managed six device operators; built team and coached them to achieve company goals; created GCP compliant protocols for existing studies and monitor studies.
- Wrote SOPs and revised User's Manual.
- Represented users of innovative medical device in complaint review and design review meetings.
- Monitored incoming data for three studies, managed daily operations on two studies.
Consultant/Clinical Program Manager
1998
BRM Capital (then BRM Technologies, Ltd.), Jerusalem (Device Start-up)
- Provided 3-day needs analysis; subsequently hired to provide clinical trial expertise to identify Principal Investigator, develop study protocol, identify sites, and participate in all business meetings and decisions.
- Managed pilot study for what was then BRM Technologies, Ltd., VC, now BRM Capital.
- Designed, wrote protocol, and prepared IRB paperwork for innovative medical device.
- Planned logistics in different types of sites (hospital, site management organization).
- Negotiated with vendors and participated in all business meetings.
Grant Administrator, Breast Care Center
1994-1998
Cancer Center, University of California, San Francisco
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As a senior administrative analyst, managed activities for federal SPORE grant ($2.5 million/year).
- Designed, planned and coordinated projects involving 13 Principal Investigators and their support staff.
- Developed and managed the web site.
- Managed annual budget, and prepared financial and scientific reports.
- Assisted patient advocacy core develop and implement research projects.
- Independently planned and carried out four annual meetings of investigators in various locations.
Manager, Breast Care Center Clinical Research Unit
1997-1998
Cancer Center, University of California, San Francisco
- Assisted the Director in planning and developing the Unit into a Phase I/II site.
- Coordinated and tracked all pre-study activities: completed questionnaires, represented the Unit during pre-study visits, established a logistical plan to perform complicated studies, and assured prompt completion of internal review, Institutional Review Board approval and contract negotiations.
- Identified and solicited new studies using Internet and other resources.
- Initiated and maintained relationships with sponsors.
- Coordinated work load of the clinical research staff.
Liaison to Chief of Hematology/Oncology Division
1994-1995
- Assisted Chairman of Breast Committee at Cancer and Leukemia Group B (CALGB) and Principal Investigator on 3,000-patient Breast Cancer clinical trial.
- Relayed questions, then answers, between Chief and study site personnel.
- Solved operational problems by streamlining processes and creating an infrastructure that allowed efficient performance of the study.
Scientific Coordinator
1989-1994
German-Israeli Foundation for Scientific Research and Development, Jerusalem, Israel
- Began as off-site word processor, advanced to work in-house on database. By 1993, wrote queries and reports, handled troubleshooting and training, produced publications and assisted with large conferences.
- Assisted in developing a large relational database as user representative.
- Managed the database and provided user support.
- Located and negotiated with vendors.
- Edited and produced publication of scientific promotional material.
Military service
1983-1985
Israeli Defense Forces, Israel
Computer Skills
Computer proficiencies include the following, as well as several proprietary applications:
| Power User | Intermediate User | Familiar With |
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Education
Hebrew University, Jerusalem, Israel
- M.S. (cum laude) in Biological Chemistry, 1992
- B.S. in Biology with minors in Mathematics and Computer Science, 1989
Continuing Education
- ISPI Institute, San Francisco, 2009
- Supervisory Development Lab, University of California, Berkeley, 2002
- ArsDigita Boot Camp, ArsDigita, Berkeley, 2000
- Introduction to GCP and Auditing: DIA, Jerusalem, 2000
- Introduction to Project Management, UCSF, San Francisco, 1996
- Microeconomics course, Open University, Tel Aviv, 1993
- Social Psychology course, Open University, Tel Aviv, 1993
VOLUNTEER WORK
- Congregation B'nai Shalom, Organizational Development, Chair of Education and Publicity, Board Member
- Volunteer Usher, Aurora Theatre, Berkeley, Post Street Theatre, San Francisco, and others
- Court Appointed Special Advocate (CASA)
- Contra Costa International Jewish Film Festival
PUBLICATIONS
Gomberg-Malool, S., Ziv, R., Re'em, Y., Posner, I., Levitzki, A. and Orly, J. 1993. Tyrphostins inhibit follicle-stimulating hormone-mediated functions in cultured rat ovarian granulosa cells. Endocrinology. 132(1):362-370.
5 years of Successful German-Israeli Cooperation. 1994. German-Israeli Foundation for Scientific Research and Development. Seri Gomberg-Malool and Erwin Asher, Co-editors.