Bringing analytical, social and leadership skills to your operation can mean the difference between maintaining your business and growing it in this tough economy. I am a take-charge, dynamic, entrepreneurial operations manager with experience in a variety of fields, including business management, clinical trials and computer programming.
Advancing company goals while promoting a professional atmosphere through team development and staff motivation.
Effective, communicative, flexible, and creative.
Successfully interacts with people from many disciplines - from scientists to carpenters. Understands the big
picture without losing sight of critical details.
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
- 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.