Seri R. Gomberg

Objectives: To facilitate organizational effectiveness through providing leadership and management for research and development efforts.

To facilitate the use of computers and the internet in medicine and clinical research

HIGHLIGHTS

Technical skills Coordinating software projects Writing specifications for software development Writing XML files describing clinical trials in CDISC format Working with QA to develop and implement test scripts for validation Managing database and writing reports Writing websites in HTML and trained in writing database backed web sites using TCL, SQL and AOLserver

Clinical research skills Designing and writing protocols according to ICH-GCP Managing technical staff Managing studies Designing and writing CRFs Writing Standard Operating Procedures

Managerial skills Designing and implementing processes Re-structuring workforce Improving productivity through outsourcing Motivating employees to improve quality of work Managing multiple part time employees

ACCOMPLISHMENTS

• Coordinated clinical trial software development in Electronic Medical Record (EMR) with assisted decision making.
  
• Created XML file describing a clinical trial using CDISC format.
  
• Programmed clinical trial screening into an EMR with assisted decision making.
  
• Created 3 web sites in HTML and trained in writing database-backed web sites.
  
• Managed a large relational database for 3 years, wrote queries and reports, and supported users.

• Wrote 10 clinical trial protocols and Case Report Forms (CRFs) in accordance with GCP, soliciting input from specialty physicians, statisticians and pharmacists.
  
• Assisted in developing programs for San Francisco Advocacy Core: focus groups on barriers to clinical trials, patient advocate training, and literature review.
  

• Managed employees: hired, provided guidance and motivation, defined work tasks, divided work among staff members, and scheduled work hours using limited resources.
• Re-structured operations, including designing change, changing job descriptions, presenting the change to employees, and implementing the changes.
  
• Reviewed and revised work processes and procedures to improve quality of output and productivity.
  
• 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.
  
• Assisted senior management in gathering data and making business decisions in medical device company.
  
• Administered translational research grant, resulting in efficient operations on the grant and effective management of bureaucratic processes.

EDUCATION

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

Courses:

• Supervisory Development Lab
  
• ArsDigita boot camp: The mechanics of using Tcl, SQL, and running the Web server
  
• Introduction to GCP and Auditing Training Course
  
• Workshop on Clinical Data Management
  
• Microeconomics
  
• Social Psychology
  

Coordinated efforts in computerizing clinical trial screening and management; designed and implemented clinical trial software as part of an Electronic Medical Record (EMR) in California, 2000-2001

Designed and implemented clinical trials at two medical device startups in Israel, 1998 - 2000

Administered scientific research program and managed the UCSF Breast Care Center Clinical Research Unit, 1994-1998

Managed database, 1989-1994

Military service, 1983-1985, Israeli Defense Forces

References available upon request.

Updated November 2006