Data Integrity Specialist, Quality Assurance (Computer System Validation)

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds….

ClinChoice is searching for a Data Integrity Specialist, Quality Assurance Computer Systems Validation (CSV) to work with one of our partner biopharmaceutical companies. This is a full-time (1 FTE) temporary employment position to the end of 2026 initially.

The Data Integrity Specialist will focus on Innovative Medicine Supply Chain systems, primarily from our client in Beerse. Hybrid working with 2 days working from home per week is permitted.   

ClinChoice is a global full-service CRO with a strong focus on quality, professional development and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client counter-parts.  

 

Main Job Tasks and Responsibilities:

 

• Cooperate with multifunctional teams to assess local systems and equipment.
• Define risks and vulnerabilities for the local systems and equipment.
• Provide Data Integrity guidance and support towards local Subject Matter Experts.
• Define remediation activities and create Data Integrity plans.
• Act as local Process Owner for Data Integrity.
• Support the Small Molecules Data Integrity Community of Practice.
• Organize and lead sessions with Data Integrity representatives of multiple sites.
• Assist site Subject Matter Experts with the assessment process of all site specific systems and equipment.
• Assist Site Subject Matter Experts with Data Flow Mapping and Risk Assessments.
• Organize, manag