Manager, Clinical Quality Assurance (GCP)

Alternative Resources Company

Manager, Clinical Quality Assurance (GCP)

Manager, Clinical Quality Assurance (GCP)
 
The Manager, Clinical Quality Assurance Audit chairs the Regulatory Authority team responsible for ensuring that the clinical facility is prepared for a health authority inspection, and that clinical sites are prepared per an inspection readiness plan. The Regulatory Authority team also ensures that sponsor and site inspections are appropriately facilitated by Clinical Quality Assurance. This position also manages the Clinical Quality Assurance Clinical Document Audit function which is responsible for managing (and conducting) audits of Clinical Study Reports and conducts audits of Trial Master Files. This position will also audit clinical investigational sites, perform inspection readiness visits at sites, develop both audit plans and inspection readiness plans, and provide GCP/Lessons Learned training as needed. In addition, this position will conduct audits of internal processes. All above activities are essential to obtaining marketing approvals of regulatory submissions.
 
Responsibilities
  • Chair the Regulatory Authority team and ensure that the clinical facility and clinical sites are prepared for clinical inspections and the inspections are successfully facilitated. Write Inspection Readiness Plans as necessary. Facilitate sponsor and site inspections as necessary.
  • Manage the Clinical Document Audit function, and plan, prepare, perform, and report on Clinical Quality Assurance audits of Clinical Study Reports and Trial Master Files
  • Develop Study Audit Plans and prepare, perform, and report on Clinical Quality Assurance audits of investigator sites
  • Plan, prepare, perform, and report on Clinical Quality Assurance audits of internal processes
  • Provide GCP and Lessons Learned training
Qualifications
  • BS/MS degree in relevant field with 4-7 years of experience in Clinical Quality Assurance methods and processes in industry setting. Related experience (for example, several years of clinical research study monitoring with knowledge of Clinical Quality Assurance processes) will be considered in lieu of direct Clinical Quality Assurance experience.
  • GCP and Auditing experience required.
  • Ability to travel 25-50% of the time.