TMF Specialist - Hybrid (Poland)

IQVIA seeks a Trial Master Files (TMF) Specialist to manage records across clinical trial projects in a hybrid Warsaw role. The position requires coordinating file retrieval, ensuring regulatory compliance, and serving as a liaison between Records Management and project teams while maintaining inspection readiness.

Responsibilities

• Conduct comprehensive TMF reviews including crosscheck and co-dependency verifications for inspection readiness
• Monitor team outputs and coordinate record retrieval requests from users and departments
• Ensure filing accuracy and compliance with SOPs and customer file plans
• Oversee transfer, recall, and disposition of records to storage facilities and manage record disposal
• Train team members on records management procedures and serve as primary client contact

Requirements

• High school diploma or equivalent education
• 3+ years of records management experience in clinical or research environment
• Strong knowledge of ICH, GCP, and applicable regulatory requirements
• Proficiency with records management technology applications
• Excellent written and oral English communication skills
• Ability to manage multiple tasks and competing priorities under pressure
• Leadership capability to train and direct team members

Compensation: zł83,000.00 - zł196,600.00 base annual