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 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

　　• High School Diploma or equivalent

　　• 3-4 years' experience working in revelant clinical research environment. Equivalent combination of education, training and experience.

　　• Attention to detail and accuracy in work.

　　• Good time management and prioritization 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.

　　• 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 (it may or may not be the same days every week based on the work priorities and sponsor deadlines).

　　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

　　IQVIA is a world leader in using data, technology, advanced analytics, and expertise to help customers drive healthcare – and human health – forward. Together with the companies we serve, we are enabling a more modern, more effective and more efficient healthcare system, and creating breakthrough solutions that transform business and patient outcomes.

　　To get there, it takes diverse skills and a curiosity to explore new possibilities. No matter your role, everyone at IQVIA, including our colleagues at Q² Solutions, contributes to our shared goal of improving human health. Thank you for your interest in growing your career with us.

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