Qualifications
Highlights
- M.S. in Biochemistry; B.S. in Biology, minor in Math and Computer Science
- Over 10 years’ job-related experience
- Process design and improvement, cradle to grave
- Regulated field background: medical, clinical (human) research, grant administration, residential construction, welfare eligibility, including 5 years in the UC system
- Effective communication and relationship building with end users, scientists, business leaders and technical staff
- Collaboration and relationships cultivation with clients, vendors and colleagues
- Program management
- Project management
Core Competencies include
- Natural tendency to consider both big picture and details, allowing for excellent strategic and operational leadership.
- Effective collaboration skills with people from a wide range of levels and backgrounds.
- Superior oral and written communication skills, including presentations to large groups.
Professional Experience
PG&E, San Francisco Bay Area, CA
Expert Program Manager
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2021-2024
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Tracks, manages and packages responses to data requests:
- Designed and improved processes to promote standard work.
- Maintained relationships and communication lines with a broad range of co-workers to facilitate completion of data quality improvement projects.
- Documented and facilitated removal of roadblocks to data quality improvement.
- Supported data quality Subject Matter Experts by onboarding, facilitating research and solution generation conversations, and tracking data maturity measures.
- Facilitated business engagement in software development, including managing intake for new technology products and facilitated engagement for small product development.
- Participated in developing blueprint and roadmap for technology product development.
Senior Case Management Analyst
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2019-2021
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- Developed SharePoint list and process to manage a large volume of data requests.
- Worked with leaders at all levels to strategically develop responses.
- Edited data responses to conform to requestor and company style and templates.
- Facilitated conversations to review responses, ensuring accuracy and completeness.
- Clarified data requests with regulator.
Senior Records and Information Management Analyst
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2017-2019
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- Imparted record and information management (RIM) concepts and principles to clients.
- Presented at All Hands meetings, including leaders, with >200 participants.
- Developed and revised metrics for Paper Reduction initiative.
Senior Technical Document Management Analyst
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2013-2017
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Published guidance documents to the Technical Information Library:
- Facilitated process development by creating Visio flow charts of complex processes and providing step-by-step instructions
- Trained staff members in using D2 database to find documents
- Maintained the technical document library (currently in Documentum; previously in Protégé, FrontPage (html) and FileNet)
- Supported departmental efforts using SharePoint libraries and lists
- Researched document histories
- Analyzed data and increased data consistency by reviewing data and identifying outliers
Computer Skills Instructor
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2012-2013
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The English Center, Oakland, CA
- Classroom training for professionals in basic computer skills, Word and Excel
JVS (Jewish Vocational Services), San Francisco, CA
- Facilitate job seekers in eight job search skills workshops, including job search planning, resume writing,
interviewing and networking.
- Developed curriculum and trained:
- Seven classes in Word and Excel for professionals at Laguna Honda Hospital; over 70 staff trained in
fourteen sessions
- Fourteen San Francisco Environment interns in Excel and GoogleDocs
- Fifteen Healthcare Bridge participants in Excel
- Trained seventeen public assistance recipients in Word and Outlook.
Welfare Eligibility Worker
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2010-2011
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County of Marin, San Rafael, CA (temporary position)
- Provided customer service to 60 new applicants to welfare programs per month:
- Processed applications
- Interviewed clients
- Explained required verifications
- Notified clients of decisions
- Explained benefits and reporting requirements
- Assisted other workers in researching, troubleshooting and solving issues with software, including e-Apps and Imaging.
C-IV Trainer and Implementation Support Specialist
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2009-2010
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SolutionsWest, Sacramento, CA (contract)
Provided classroom training and over-the-shoulder implementation support on specialized welfare
programs to county employees. Participated in six week classroom software training, resulting in effective delivery of provided curriculum.
- Delivered existing training content. Provided first-line technical support in training lab.
- Provided over-the-shoulder support to welfare workers at their desks in using the C-IV software to track their
clients.
Consultant (Self employed)
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2003-2009
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Provide creative analysis of business operations for clients in a variety of business endeavors. Support clients to make them more efficient and effective.
- Managed daily operations for contractor (sole-proprietor).
- 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.
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 and consensus building skills.
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
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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
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1994-1998
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Cancer Center, University of California, San Francisco
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
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1997-1998
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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
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1994-1995
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- 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
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1989-1994
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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
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1983-1985
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Israeli Defense Forces, Israel
Computer Skills
Computer proficiencies include the following, as well as several proprietary applications:
Power User
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Intermediate User
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Familiar With
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- MS-Word
- MS-Excel
- MS-PowerPoint
- HTML
- Formulas and functions
- Mail Merge
|
|
- Pivot Tables
- MS Access
- SalesForce
- QuickBooks
- SQL, TCL
- RemarkScan
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Hebrew University, Jerusalem, Israel
- M.S. (cum laude) in Biological Chemistry, 1992
- B.S. in Biology with minors in Mathematics and Computer Science, 1989
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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
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VOLUNTEER WORK
- Volunteer Usher: Aurora Theatre, Berkeley, Post Street Theatre, San Francisco, and others
- Film Festival Volunteer, San Francisco Jewish Film Festival and San Francisco International Film Festival
- Court Appointed Special Advocate (CASA)
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.
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