Seri R. Gomberg

Contra Costa County, CA
Email

Cell phone: (415) 425-7797

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

Consultant	Jan. 2003 - Present
Clinical trial operations Project management Account management

Manager, Field Operations and Office Administration

Dec. 2001 – Jan. 2003

University of California, Berkeley, California

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

Clinical Informatics Analyst

Sept. 2000 - Sept. 2001

iKnowMed, Berkeley, California

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

Manager, Clinical Operations

Aug. 1999 - March 2000

Karmel Medical Acoustic Technologies, Yokneam Illit, Israel (Device Start-up)

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

Consultant/Clinical Program Manager

Aug. 1998 - Dec. 1998

BRM Capital (then BRM Technologies, Ltd.), Jerusalem (Device Start-up)

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

SPORE Administrator

1994-1998

Manager, Breast Care Center Clinical Research Unit

1997-1998

Liaison to Chief of Hematology/Oncology Division

1994-1995

Cancer Center, University of California, San Francisco

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:

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.

Scientific Coordinator

1989-1994

German-Israeli Foundation for Scientific Research and Development, Jerusalem, Israel

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

Military service	1983-1985
Israeli Defense Forces, Israel

EDUCATION

MS, cum laude, Department of Biological Chemistry	1989-1992
Hebrew University, Jerusalem
Advisor: Prof. Joseph Orly, Department of Biological Chemistry Thesis: Inhibition of Hormone-Induced Steroid Synthesis in Ovary Cells: Possible Involvement of a Tyrosine Kinase

BS, Major: Biology; Minor: Mathematics and Computer Science	1985-1989
Hebrew University, Jerusalem

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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Manager, Field Operations and Office Administration	Dec. 2001 – Jan. 2003
University of California, Berkeley, California
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

Clinical Informatics Analyst	Sept. 2000 - Sept. 2001
iKnowMed, Berkeley, California
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

Manager, Clinical Operations	Aug. 1999 - March 2000
Karmel Medical Acoustic Technologies, Yokneam Illit, Israel (Device Start-up)
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

Consultant/Clinical Program Manager	Aug. 1998 - Dec. 1998
BRM Capital (then BRM Technologies, Ltd.), Jerusalem (Device Start-up)
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

SPORE Administrator	1994-1998
Manager, Breast Care Center Clinical Research Unit	1997-1998
Liaison to Chief of Hematology/Oncology Division	1994-1995
Cancer Center, University of California, San Francisco
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:
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.