TMF Specialist: Trial Master File & Records Lead

IQVIA; Warszawa; On-site; PLN 83,000 - 197,000; Full time

Job summary

IQVIA is seeking a Records Management professional in Warsaw to act as a liaison for TMF, ensuring quality and regulatory compliance across multiple projects and sites. You will oversee TMF review, cross-checks, and readiness for inspections while adhering to SOPs and client expectations.

The role requires 3 years in records management, strong ICH/GCP knowledge, and excellent English. You may lead teams, train staff, and coordinate transfers, recalls, and disposal of records with IQVIA clients.

Qualifications

• 3 years of experience working in a Records Management environment.
• Strong knowledge of ICH, GCP and relevant local regulations.
• Ability to lead others and manage multiple tasks within defined timelines.
• Excellent written and spoken English.
• Experience with records retrieval and transfer processes.

Responsibilities

• Monitor team outputs to meet project deadlines and goals.
• Coordinate retrieval of records and prepare closed studies for transfer to clients.
• Monitor filing accuracy and SOP compliance for IQVIA records.
• Maintain records center security to protect integrity and ensure SOP compliance.
• Interface with departments to support retrieval projects and meet information needs.
• Train team members on records management tasks, policies and procedures.
• Serve as primary contact for clients.
• Coordinate transfer, recall, and disposition of records to storage centers.
• Oversee disposal of obsolete records and maintenance of space and equipment.
• Assist management with strategic goals, plans, and resource projections for records management projects.
• May function as team leader for records management projects.

Skills

Regulatory knowledge

Leadership

Communication skills

Attention to detail

Multitasking

Education

High School Diploma or equivalent

Tools

Records management tools

Job description

IQVIA is seeking a Records Management professional in Warsaw to act as a liaison for TMF, ensuring quality and regulatory compliance across multiple projects and sites. You will oversee TMF review, cross-checks, and readiness for inspections while adhering to SOPs and client expectations.

The role requires 3 years in records management, strong ICH/GCP knowledge, and excellent English. You may lead teams, train staff, and coordinate transfers, recalls, and disposal of records with IQVIA clients.