TMF Quality Project Lead
This is an exciting opportunity for TMF Quality Project Lead role within Records Management department. If you are motivated, experienced in cross functional collaboration, have strong communication skills and consider yourself as a good team leader, please review and apply!
Serve as the liaison between Records Management and user departments regarding Trial Master files. Apply Records Management expertise to provide project related assistance. 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 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.
Serve as primary contact for clients.
Collect data and assist in the preparation of statistical reports for management of record center operations, as appropriate or as requested.
Coordinate transfer, recall, and disposition of records to commercial records storage centers.
Assist management with the implementation of strategic goals, plans, cost proposals, and resource projections for records management projects.
May function as team leader for records management projects.
Bachelor´s Degree in Life Sciences or related field.
At least 3 years' experience working in a Records Management environment.
Strong oral and written communication skills and good command of English Language.
Strong knowledge of applicable research and 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 management environments.
Ability to handle multiple tasks and projects within defined timelines and balance competing priorities.
Ability to establish and maintain effective working relationships with internal and external clients.
At IQVIA, 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. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 70,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.
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