Seri R. Gomberg
HIGHLIGHTS OF QUALIFICATIONS
Wide
variety of technical, clinical research and managerial skills (see functional resume for
details).
- Wrote a CDISC (XML)
file to export data for a clinical trial from an Electronic Medical Record (EMR) into a SAS ready document;
rapidly learned HTML, TCL, SQL and AOLserver, and
other programs as needed
- Designed
and wrote ICH-GCP compliant protocols for more
than 5 studies, including CRFs and Standard
Operating Procedures (SOPs)
- As
supervisor re-structured processes and workforce, reduced research cost to
50% while maintaining productivity and quality, managed part time
employees remotely, including technical staff
EMPLOYMENT
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Consultant
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Jan. 2003 - Present
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- Clinical trial operations
- Project management
- Account management
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Manager, Field Operations and Office
Administration
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Dec. 2001 – Jan. 2003
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University of California, Berkeley, California
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- Managed 14 employees, including field staff
- Planned and implemented restructuring efforts,
to improve productivity and cost-effectiveness
- Negotiated and managed outsourcing
relationships, including specialized expertise in the project
- As member of senior management team, provided
leadership when needed
- Wrote specifications for database used to track
data collection
- Designed and improved work procedures
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Clinical Informatics Analyst
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Sept. 2000 - Sept. 2001
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iKnowMed,
Berkeley, California
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- Coordinated efforts at computerizing clinical
trials within an Electronic Medical Record (EMR)
- Created XML file describing a clinical trial
using CDISC format
- Programmed clinical trial screening to review
Electronic Medical Record (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
- Maintained capture of CRF data within patient
chart written by others
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Manager, Clinical Operations
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Aug. 1999 - March 2000
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Karmel
Medical Acoustic Technologies, Yokneam Illit, Israel (Device Start-up)
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- Wrote 7 protocols, reviewed study design, and
wrote Case Report Forms (CRFs), adhering to
Good Clinical Practices (GCP)
- Represented users of novel medical device in
complaint review and design review meetings, discussing user issues with
software engineers/programmers, resulting in better priorities in
selecting modifications in subsequent software releases
- Managed device operators (6 employees):
provided guidance and motivation, defined work tasks, divided them among
staff members, and scheduled work hours using limited resources
- Monitored incoming data for 3 studies, managed
daily operations on 2 studies
- Wrote Standard Operating Procedures (SOPs) and
revised User's Manual
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Consultant/Clinical
Program Manager
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Aug. 1998 - Dec. 1998
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BRM Capital (then BRM
Technologies, Ltd.), Jerusalem
(Device Start-up)
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- Managed pilot study design, wrote protocol, and
prepared IRB paperwork for novel medical
device
- Assisted in selecting principal investigator,
managed study site selection, planned logistics in different types of
sites (hospital, site management organization - SMO)
- Negotiated with vendors (Contract Research
Organizations - CROs) and participated in all
business meetings
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SPORE Administrator
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1994-1998
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Manager, Breast Care Center Clinical
Research Unit
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1997-1998
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Liaison to Chief of
Hematology/Oncology Division
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1994-1995
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Cancer Center, University of California, San Francisco
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As
SPORE Administrator:
Managed programmatic, operational and fiscal activities for federal SPORE
grant ($2.5 million/year) in Breast Cancer:
|
- Designed, planned and coordinated projects
involving 13 Principal Investigators and their support staff
- Developed and managed the web site
- Planned and managed all fiscal activity
- Assisted patient advocacy core develop and
implement research projects
|
|
As
Manager, Breast Care Center
Clinical Research Unit:
Assisted Director, Breast Care Clinical Research Unit, Dr. Debasish Tripathy, in planning
and developing the Unit into a Phase I/II site:
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- Coordinated and tracked all pre-study
activities, including representing the Unit during pre-study visits,
establishing a logistical plan to perform complicated studies, and assuring
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
|
|
As Liaison to Chief of
Hematology/Oncology Division, I. Craig Henderson, MD
Assisted Dr. Henderson in his capacities as Chairman of Breast Committee at
Cancer and Leukemia Group B (CALGB) and Principal
Investigator (PI) on 3000-patient Breast Cancer clinical trial:
Dealt with all issues that required PI's attention, including communicating
questions to PI and answers to medical personnel, solving operational
problems by streamlining processes and creating an infrastructure that
allowed efficient performance of the study.
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Scientific Coordinator
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1989-1994
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German-Israeli
Foundation for Scientific Research and Development, Jerusalem,
Israel
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- Assisted in development of a large relational database as user representative
- Managed the database and provided user support
- Organized conferences
- Located and negotiated with vendors
- Edited and produced publication of scientific
promotional material
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Military service
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1983-1985
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Israeli Defense Forces, Israel
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MS, cum laude,
Department of Biological Chemistry
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1989-1992
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Hebrew
University, Jerusalem
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Advisor: Prof. Joseph Orly,
Department of Biological Chemistry
Thesis: Inhibition of Hormone-Induced Steroid Synthesis in Ovary
Cells: Possible Involvement of a Tyrosine Kinase
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BS, Major: Biology;
Minor: Mathematics and Computer Science
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1985-1989
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Hebrew
University, Jerusalem
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Courses:
- Regulatory Affairs Training Course: Part I: The IND &
Part II: The CTD/NDA Phase, 4 days, 2004
DIA, Boston
- Supervisory Development Lab: campus culture, leadership, hiring, communication skills,
policies, and resources, 56 hours, 2002
University of California, Berkeley
- ArsDigita boot camp: The mechanics of using Tcl,
SQL, and running the Web server, 1 week, 2000
ArsDigita, Berkeley
- Introduction to GCP and Auditing
Training Course, 3 days, 2000
DIA, Jerusalem
- Workshop on Clinical Data Management, 2 days, 1997
UCSF Cancer Center, San Francisco,
CA
- Introduction to Project Management, 2 days, 1996
UCSF Training, San Francisco, CA
- Microeconomics Course, 1
semester, 1993
Open University, Tel Aviv, Israel
- Social Psychology Course,
1 semester, 1993
Open University, Tel Aviv, Israel
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.
References available upon request.
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