meir pinco

About

Location: San Francisco Bay Area; Industry: Biotechnology ... biostatistics clinical research from the University of California, San Francisco. ... Computer System Validation, Project Management, Regulatory Compliance, ... Sr Software Engineer ... to work with Meir Pinco on multiple projects at Gilead sciences where he was a...

Country

united states

City

sunnyvale

Industry

biotechnology

Skill

biotechnology, pharmaceutical industry, clinical trials, computer system validation, validation, lifesciences, clinical data management, 21 cfr part 11, bioinformatics, cross functional team leadership, management, pharmacovigilance, drug safety, data management, edc, informatics, drug development, project management, software development, computer information systems, change management, sop, change control, r&d, data analysis, vendor management, gxp, biopharmaceuticals, lims, gcp, regulatory affairs, cro, full sdlc, object oriented software, relational databases, capa, ind, regulatory requirements, technology transfer, protocol, strategic planning, biostatistics, strategy, epidemiology, clinical systems implementation, regulatory compliance, business analysis, roadmap creation

Experience

senior informatics scientist

merck

2016-1 - 2019-1 · 3 yrs 1 mo

senior bioinformatics scientist

surromed

2000-1 - 2005-1 · 5 yrs 1 mo

Established clinical informatics platform for this early stage biomarker discovery startup. Conducted clinical data management activities (Trial design/setup and execution- EDC, data transformation, cleanup, reports) for numerous global clinical studies.

software engineer

domain pharma solutions

1996-1 - 1998-1 · 2 yrs 1 mo

Designed and implemented (SmallTalk, Java) modules for Presidio Clinical EDC platform

consultant clinical drug development systems and data management

qualitasoft

2014-1 - 2016-1 · 2 yrs 1 mo

* Pharmacyclics Inc. * Advising, compliance, project and vendor management for Argus Safety database cloud services transition, system upgrade and data migration. * Saama Technology, * Provided informatics expertise in pharmacovigilance and epidemiology to help Saama Technology respond to Gilead’s RFP for proactive signal detection platform development project.

senior software engineer

confer software

1998-1 - 2000-1 · 2 yrs 1 mo

* Designed and implemented (C++) modules of ConferWeb, xml based process management platform and applications. * Configured ConferWeb for several Disease Management Solutions per customer’s business process * requirements. * Authored Reports for a Disease Management solution using Actuate Reporting Suite.

manager of information systems

ppd

2005-1 - 2006-1 · 1 yr 1 mo

* Managed the clinical bioinformatics platform and built and managed successful bioinformatics and software development teams, delivering proprietary Java and C# software solutions. * Oversaw the full software development lifecycle (SDLC). * Managed relationships with partner companies, creating award-winning tools. * Integrated Spotfire with SurroStat, which won Bio-IT World’s 2004 Best Practices Award. * Managed Spotfire DecisionSite and Insightful S-PLUS Server integration solution. * Managed implementation of Thermo Electron LIMS system serving the biomarker discovery R&D labs. * Developed proteomic and metabolomics informatics software platform to process, visualize and load into SurroMed’s LC/GC-MS data warehouse. * Architected the development of ChemSearch, a chemical substance search J2EE web application, as well as SurroMed’s LC-MS informatics platform.

director of safety information systems and data management

gilead sciences

2006-1 - 2013-1 · 7 yrs 1 mo

* Built and managed the US/EU Drug Safety Information Systems team. Managed nine-figure project budgets. Led the full project lifecycle, from conception to deployment in a highly regulated environment. * Led the integration of the Drug Safety information system over multiple global acquisitions. * Implemented a new Adverse Events Management System globally within strict budgets and deadlines. * Developed and implemented the Gilead Drugs Safety Signal Detection platform, Drug Safety Data Warehouse, and Drug Safety Database, improving drug safety data retrieval and analysis.

Education

the university of california

university of california, san francisco

epidemiology

2013-1 - 2014-1 · 1 yr 1 mo

The Advance Training in Clinical Research certificate program is a 4 academic quarter program intended for scholars who desire rigorous training in the methods and conduct of clinical research. This includes instruction in the epidemiologic and biostatistical methods used in observational or experimental patient-oriented, translational, epidemiologic, comparative effectiveness, behavioral, outcomes, or health services research.