Senior Manager, Clinical Quality Assurance

Alternative Resources Company

Senior Manager, Clinical Quality Assurance

Senior Manager, Clinical Quality Assurance
 
The Senior Manager, CQA oversees GCP activities, Investigator Sites and CROs, leads GCP audits and inspection readiness. The successful hire will ensure high quality execution of clinical trials from first in human through launch and beyond. This person will manage cross-functional relationships with internal and external stakeholders and be the primary Quality Assurance representative to clinical teams.
 
Responsibilities
  • Proactively provide GCP QA support for clinical development activities to protect patient safety & wellbeing, maintain data integrity, and support operational excellence
  • Independently conduct Clinical Investigator Site Audits, GCP Document Audits (Clinical Study Reports and Trial Master Files and support Vendor/System audits
  • Author and manage Audit Plans and Audit reports
  • Facilitate ongoing quality improvement through communication of audit results, CAPAs and GCP guidance and consultation to clinical teams
  • Support health authority inspections
  • Review and provide input to clinical documentation (e.g. protocols, study reports, IBs, ICFs, etc.)
  • Compile and analyze audit metrics to communicate trends to business groups
  • Conduct GCP training sessions for business groups
 
Requirements
  • Bachelor's degree required with minimum 5-8 years relevant GCP experience including 2-5 years of GCP auditing experience
  • Technical and administrative capabilities to independently carry out routine and complex audits
  • Experience of inspection management
  • Fundamental knowledge of US, EU and international regulatory standards and guidelines for the conduct of clinical trials
  • Strong analytical skills and report writing skills
  • Ability to demonstrate tact as a representative of the CQA Department
  • Must have professional communications skills, strong independent time management skills and the ability to manage multiple projects concurrently
  • Ability to travel (minimum of 25%), primarily within North America
  • Work location – on-site at office or remote within ~120 mile radius of office, and as needed able to work on-site, approximately 2 days/week