Clinical Auditor

We are seeking a 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 involved with IQVIA contracts
• Evaluating audit findings and preparing reports for operations staff, management, and customers
• Providing interpretation and consultation to project teams on regulations, guidelines, compliance status, and policies and procedures
• Reviewing and approving investigations, Root Cause Analysis (RCA), Corrective Action Prevention (CAPA), and Effectiveness Check (EC) plans
• Evaluating policies and procedures for compliance with applicable regulations and guidelines
• Maintaining the electronic quality management system (eQMS) and providing support in relation to the audit lifecycle
• Leading and collaborating on QA initiatives and projects for quality and process improvements
• 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 assigned tasks and work independently
• Ability to manage multiple projects

The potential base pay range for this role is zł 168,100.00 - zł 312,100.00 per year.