Montreal, QC Canada
Galenvs Sciences is looking for a Clinical Services Manager to lead our clinical research and diagnostic laboratory. The candidate would be responsible for managing and overseeing all clinical service functions within the organization as well as assisting in the growth and promotion of the services.
- Maintain clinical research and diagnostic laboratory infrastructure, including all related regulatory affairs
- Oversee and manage clinical research/testing operations and personnel
- Develop clinical laboratory workflows
- Develop, conduct, and validate new analytical methods for clinical testing in compliance with Quality System guidelines
- Work closely with product development and sales to meet client service requests.
- Write/implement SOPs for clinical research operations
- Plan budgets and financials for clinical research projects
- Prepare requests for quotes (RFQs) and proposals (RFPs)
- Ensure laboratory quality assurance (GCP, GCLP, GDP, SOPs) and attend qualification audits from clients and regulatory agencies (HC, FDA, EMA)
- MSC in Microbiology/Biochemistry/Biomedical Sciences or related field
- 2 years of clinical management experience
- 5 years of clinical/diagnostic experience
- Experience in ISO 15189:2012 environment
- Solid understanding of GCP and ICH guidelines for clinical development