TMF Analyst Full-time Job

Full Job DescriptionJob Overview Provide Trial Master File TMF 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 executionAssist in updating and maintaining complex data in systems within project timelines and per project plansCoordinate the retrieval of records requested by users and prepare closed studies to final destination within agreed timelinesConduct and manage scanning processes and train staff on scanning processesInterface with departments to support retrieval projects and ensure information needs are metServe as primary contact for internal/external clientsMonitor and review filing accuracy and compliance to IQVIA or customer file plans and Standard Operating Procedures SOPs where applicableMaintain records center security to protect record integrity by ensuring compliance to SOPsMay coordinate transfer, recall, and disposition of records to commercial records storage centersOversee disposal of obsolete records and ensure efficient maintenance of records storage space, supplies, and equipmentTrain team members on records management tasks, policies, and proceduresEstablish and maintain effective internal and external client communicationsDesign and administer records management systems and processesEnsure project deadlines, commitments, and goals are met by monitoring projects daily outputsMay function as team leader for records management projects Qualifications High School Diploma or equivalent Req3-4 years' experience working in revelant 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.Unaided lifting of objects up to 40 pounds/18kgs.May require to work in shifts. IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com