Trial Master File Records Specialist

IQVIA LLC; Warszawa; Hybrid; PLN 83,000 - 197,000; Full time

Job summary

IQVIA Warszawa is seeking an experienced Records Management Associate to provide Trial Master File (TMF) quality checks and support to study teams. You will ensure compliance with SOPs and regulatory requirements while maintaining timely delivery of records and data within project plans.

The role involves overseeing scanning processes, training staff, coordinating retrievals, and serving as the main contact for internal and external clients.

Qualifications

• Bachelor's degree or equivalent.
• 3-4 years' experience working in a Records Management technically-related area.
• Good knowledge of applicable clinical research regulatory requirements, i.e., ICH, GCP and relevant local laws, regulations and guidelines.
• Knowledge of technology applications relevant to records center 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.
• Excellent oral and written communication skills, including good command of English language.
• Position requires a significant amount of writing and keyboarding involving repetitive motions with fingers and sitting for prolonged periods of time.
• Position requires to stand, walk, sit, use hands to manipulate, handle or feel, and reach with hands and arms.
• Position requires to stoop, kneel and may need to utilize a ladder for paper files on high-density file systems.

Responsibilities

• Perform assigned complex administrative tasks to support team members with project execution
• Assist in updating and maintaining complex data in systems within project timelines and per project plans
• Coordinate the retrieval of records requested by users and prepare closed studies to final destination within agreed timelines
• Conduct and manage scanning processes and train staff on scanning processes
• Interface with departments to support retrieval projects and ensure information needs are met
• Serve as primary contact for internal/external clients
• Monitor and review filing accuracy and compliance to IQVIA or customer file plans and SOPs where applicable.
• Maintain records center security to protect record integrity by ensuring compliance to SOPs
• May 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
• Train team members on records management tasks, policies, and procedures
• Establish and maintain effective internal and external client communications
• Design and administer records management systems and processes
• Ensure project deadlines, commitments, and goals are met by monitoring projects daily outputs
• May function as team leader for records management projects

Education

Bachelor's degree or equivalent

3-4 years' experience working in a Records Management technically-related area

Strong organizational, planning, and decision making skills

Excellent oral and written communication skills, including good command of English language

Job description

IQVIA Warszawa is seeking an experienced Records Management Associate to provide Trial Master File (TMF) quality checks and support to study teams. You will ensure compliance with SOPs and regulatory requirements while maintaining timely delivery of records and data within project plans.

The role involves overseeing scanning processes, training staff, coordinating retrievals, and serving as the main contact for internal and external clients.