to December 2006
- 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)
- Part-time in San Francisco
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.
Full-time Paris (France)