Job Summary
A biotechnology research company has a current position open for a Remote GCP Compliance Associate Director.
Candidates will be responsible for the following:
- Oversee management and maintenance of an electronic Trial Master File system
- Lead the development and implementation of internal processes related to GCP and SOPs
- Serve as subject matter expert concerning GCP and provide quality and compliance guidance
Qualifications for this position include:
- Bachelor’s degree in a scientific discipline or health related field (e.g., nursing, pharmacy, physician’s assistant) with an advanced degree preferred
- A minimum of 10+ years of clinical research experience (or equivalent)
- Demonstrates thorough knowledge and understanding of key regulatory authorities, ICH Guidelines, and GCPs governing clinical trial conduct
- Very strong verbal, written and presentation skills are required. Experience of leading of a matrixed cross-functional team
- Ability to work independently and in a team environment
