TMF Specialist: Trial Master File Liaison & Compliance

IQVIA LLC; Warszawa; On-site; PLN 118,000 - 197,000; Full time

Job summary

IQVIA LLC is seeking a Records Management professional to act as the liaison between Records Management and user departments for Trial Master Files (TMF). The role applies RM expertise to support multiple projects across sites, ensuring compliance with SOPs, GCP/ICH and relevant local laws, and achieving inspection readiness through thorough TMF reviews.

Key responsibilities include coordinating record retrieval, training staff on RM tasks, and serving as a primary client contact while managing

Qualifications

• High School Diploma or equivalent.
• 3 years of experience working in a Records Management environment.
• Strong knowledge of applicable research and regulatory requirements such as ICH and GCP.
• Knowledge of technology applications relevant to records management environments.
• Ability to perceive and analyse problems, develop solutions, and make sound decisions.
• Ability to handle multiple tasks and projects within defined timelines and balance priorities.
• Ability to remain focused with regards to details under pressure.
• Strong organizational, planning, and decision making skills.
• Excellent oral and written communication skills, including good command of English.
• Ability to establish and maintain effective working relationships with internal and external clients.
• Ability to lead others.
• Attention to writing and keyboarding with repetitive motions.

Responsibilities

• Serve as liaison between Records Management and user departments regarding TMF.
• Apply Records Management expertise to provide project related assistance across complex projects/sites.
• Ensure work adheres to SOPs, regulatory requirements, and quality/timeline metrics.
• Conduct comprehensive TMF review including crosscheck and co-dependency checks for inspection readiness.
• Coordinate retrieval of records and prepare closed studies for transfer to clients.
• 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 manage storage space and equipment.
• May function as team leader for records management projects.

Job description

IQVIA LLC is seeking a Records Management professional to act as the liaison between Records Management and user departments for Trial Master Files (TMF). The role applies RM expertise to support multiple projects across sites, ensuring compliance with SOPs, GCP/ICH and relevant local laws, and achieving inspection readiness through thorough TMF reviews.

Key responsibilities include coordinating record retrieval, training staff on RM tasks, and serving as a primary client contact while managing