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TMF Specialist (Bulgaria, Poland, Slovakia)

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Primary Location: Sofia, Bulgaria Additonal Locations: Bratislava, Slovakia,SVK; Warsaw, Poland,POL Full time R1286759

Job description

Job Overview

Serve as the liaison between Records Management and user departments regarding Trial Master files. 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.

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


• High School Diploma or equivalent  
• 3-4 years' experience working in relevant clinical research environment. Equivalent combination of education, training and experience.
• Good knowledge of applicable clinical research 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 center environments.
• General knowledge of computer technology and software programs, and accurate data entry skills.
• Attention to detail and accuracy in work.
• Ability to achieve productivity despite time pressure constraints.
• Good problem solving skills.
• Strong organizational, planning, and decision making skills.
• Good time management and prioritization skills.
• Extensive knowledge of records management laws and regulations.
• Excellent oral and written communication skills including good command of English language.
• Ability to manage and lead others.
• Ability to establish and maintain effective working relationships with internal and external clients.
• Position requires a significant amount of writing and keyboarding involving repetitive motions with fingers and sitting for prolonged periods of time.
• Position is required to stand, walk, sit, use hands to manipulate, handle or feel, and reach with hands and arms.
• Position is required to stoop, kneel and may need to utilize a ladder for paper files on high-density file systems.

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