Job Summary
A contract research organization has an open position for a Telecommute GCP Inspection Lead.
Candidates will be responsible for the following:
- Directing and developing the overall management/support for inspections
- Developing clinical quality management and global clinical quality management
- Conducting strategic assessments of quality metrics and compliance needs
Applicants must meet the following qualifications:
- Travel to client’s headquarters and clinical investigator sites
- Bachelor’s degree or equivalent in relevant health care area
- 8 years of relevant experience in clinical research
- 2 years of direct experience with managing worldwide regulatory health authority inspections
- Good knowledge and understanding of clinical development programs, clinical trial processes
- Direct knowledge of GCP/ICH and worldwide regulatory health authority requirements