Title: Inspection Readiness Consultant
Location: Greater Princeton, NJ
Salary: Based on Experience + Benefits
This role will participate in the management of the Trial Master File system (paper or electronic) and will ensure that the clinical programs conducted are in a state of inspection readiness with high standards for quality. Reviews records and documents for the Trial Master File and identifies gaps and corrective actions necessary to ensure the integrity of systems, processes and clinical documentation are maintained in accordance with corporate and regulatory directives.
Inspection Readiness Consultant Responsibilities:
Management of the Trial Master File system.
- BA, BS BNS or Higher from a university in a scientific discipline or equivalent combination of education and work experience
- 6+ years pharmaceutical clinical research experience with previous roles as Senior CRA, Quality Assurance (QA),
- Experience reviewing eTMF for pre-inspection GCP and data quality attributes a must (Veeva Vault experience required)
- Experience supporting an FDA inspection and knowledge of BIMO requirements
- Health Benefits (Dental, Vision, Medical)