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Experience

Application specialist - Technical Sales consultant

SYNARC
January 2003 to December 2006
Responsibilities completed
  • Work with Data Managers and Biostatisticians and Medical Experts to write clinical trials ptotocols
  • Consult with Head of Biometry to write the data transfer specifications for drug product effect assessment
  • Work with Director of Clinical Operations and Head of Quality Assurance to comply with the FDA regulations (21 CFR Part 11, GCP, ICH).
  • Project Management from RFPs to drug products approval
  • Ergonomic software design and workflow and process optimization
  • Therapeutic areas: oncology, neurology, cardiology, metabolism and dermatology
  • ISO 9001 & Good Clinical Practises certifications, FDA regulations compliance
  • Computerized systems validation
  • Sponsors: GSK, Novartis, Sanofi, Roche, Servier, Lundbeck.
  • Technicians and Clinical Research Assistants (up to 12) coordination - international clinical trials (all phases)
Detailed Description
  • Part-time in San Francisco
Company Description

Centralized medical imaging solutions for international clinical trials. Synarc is a Contract Research Organization that provides clinical trial management and resourcing solutions to pharmaceutical, biotechnology and medical device organisations.