TMF Specialist - Hybrid (Poland)

iqvia; Warszawa; Presencial; PLN 83.000 - 197.000; Jornada completa

Descripción de la vacante

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.

Formación

• 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.

Responsabilidades

• 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.

Conocimientos

Regulatory knowledge

Leadership

Communication skills

Attention to detail

Multitasking

Educación

High School Diploma or equivalent

Herramientas

Records management tools

Descripción del empleo

Job Overview

Serve as the liaison between Records Management and user departments regarding Trial Master Files (TMF). Apply Records Management expertise to provide project related assistance across complex and multiple project(s), sites, and project teams. Ensure all work is conducted in accordance with Standard Operating Procedures (SOPs), policies, practices, good clinical practices, applicable regulatory requirements, and meets quality and timeline metrics.

The role involves comprehensive TMF review including crosscheck and co-dependency checks to ensure inspection readiness of TMF.

Essential Functions

• Ensure project deadlines, commitments, and goals are met by monitoring team's daily outputs.
• Coordinate the retrieval of records requested by users and prepare closed studies for transfer to clients.
• Monitor filing accuracy and compliance to IQVIA or customer file plans and Standard Operating Procedures (SOPs).
• Maintain records center security to protect record integrity by ensuring compliance to SOPs.
• Interface with departments to support retrieval projects and ensure information needs are met.
• Monitor and assist in the preparation of closed studies for transfer to clients per agreed due dates.
• Train team members on records management tasks, policies, and procedures
• Serve as primary contact for clients.
• Coordinate transfer, recall, and disposition of records to commercial records storage centers.
• Oversee disposal of obsolete records and ensure efficient maintenance of records storage space, supplies, and equipment.
• Assist management with the implementation of strategic goals, plans, cost proposals, and resource projections for records management projects.
• Conduct and manage processes and train staff on processes.
• May function as team leader for records management projects.

Qualifications

• High School Diploma or equivalent .
• 3 years of experience working in a Records Management environment. Equivalent combination of education, training and experience.
• Strong knowledge of applicable research and regulatory requirements, i.e., International Conference on Harmonization (ICH), Good Clinical Practice (GCP) and relevant local laws, regulations and guidelines.
• 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 competing 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 language.
• Ability to establish and maintain effective working relationships with internal and external clients.
• Ability to lead others.
• Position requires a significant amount of writing and keyboarding involving repetitive motions with fingers and sitting for prolonged periods of time.
• Regular sitting for extended periods of time.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.

The potential base pay range for this role, when annualized, is zł83,000.00 - zł196,600.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.