TMF Document Specialist - Hybrid (Bulgaria)

Job Overview

Provide Trial Master File (TMF) - Quality checks related assistance to study 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.

Ensure that project timelines are met and facilitate the orderly imaging, transfer, retention, and disposition of various project-related and business records. Administer records management systems.

Essential Functions

• 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 Standard Operating Procedures (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

Qualifications

• Bachelor's degree or equivalent

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

• 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.

• 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.

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