Clinical Auditor

We are seeking an experienced Clinical Auditor to plan and conduct independent clinical audits to assess compliance with regulations, guidelines, and operating procedures.

The successful candidate will be responsible for:

• Planning, scheduling, conducting, reporting, and closing audit activities in various countries to assess compliance with applicable regulations, guidelines, customer requirements, and project-specific instructions
• Evaluating audit findings and preparing reports for operations staff, management, and customers
• Providing interpretation and consultation on regulations, guidelines, compliance status, and policies and procedures to project teams
• Collaborating with customers and monitors to interpret audit observations and develop corrective action plans
• Reviewing and approving investigations, Root Cause Analysis, Corrective Action Prevention, and Effectiveness Check plans
• Evaluating policies and procedures for compliance with regulations and guidelines, and providing recommendations for continuous process improvements
• Maintaining the electronic quality management system and supporting the audit lifecycle
• Leading and collaborating on quality initiatives and projects
• Assisting in the training of new Quality Assurance staff
• Managing Quality Issues, presenting educational programs, and providing guidance to operational staff on compliance procedures

The ideal candidate will have:

• 5 years of experience in a GCP environment, with 3 years in Quality Assurance Site Audit
• Experience leading clinical trial Investigator site audits (at least 7-10 per year)
• Certification to conduct audits in Italy in accordance with the Italian Decree of the Ministry of Health dated 15 Nov 2011 (desirable)
• Knowledge of word-processing, spreadsheet, and database applications
• Extensive knowledge of pharmaceutical research and development processes and regulatory environments
• Strong interpersonal, problem-solving, risk analysis, and negotiation skills
• Effective organization, communication, and team orientation skills
• Ability to initiate tasks and work independently
• Ability to manage multiple projects

The potential base pay range for this role is €44,200.00 - €66,200.00 per year. The actual base pay offered may vary based on job-related qualifications, location, and schedule.