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IQVIA

TMF Quality Project Manager

IQVIA

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

Posted 5/21/2026full-timeRemote • Connecticut, Illinois, Massachusetts, North Carolina • 🇺🇸 United StatesMid-LevelSenior💰 $47,400 - $118,600 per yearWebsite

Tech Stack

Tools & technologies
Google Cloud Platform

About the role

Key responsibilities & impact
  • Serve as the liaison between Records Management and user departments regarding Trial Master Files.
  • Apply clinical research records management expertise to provide project-related assistance across multiple projects, sites, and project teams.
  • Ensure all work is conducted in accordance with Standard Operating Procedures (SOPs), policies, practices, Good Clinical Practice (GCP), and applicable regulatory requirements, while meeting quality and timeline metrics.
  • May lead teams functionally, where assigned, including awareness of scope of work, budget, and available resources.
  • Ensure project timelines are met and facilitate the orderly transfer, imaging, scanning, retention, and disposition of project-related and business records.
  • Coordinate the retrieval of records requested by users and prepare closed studies for transfer to final destinations within agreed timelines.
  • Monitor filing accuracy and compliance with IQVIA or customer file plans and Standard Operating Procedures (SOPs).
  • Conduct and manage imaging and scanning processes, and train staff on applicable imaging and scanning procedures.
  • Maintain records center security to protect record integrity by ensuring compliance with SOPs.
  • Interface with internal departments to support retrieval projects and ensure information needs are met.
  • Coordinate the transfer, recall, and disposition of records to commercial records storage centers.
  • Oversee the 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.

Requirements

What you’ll need
  • Bachelor’s degree in Records Management or a related field, or equivalent combination of education, training, and experience.
  • Minimum of four (4) years of experience working in a technically related records management environment.
  • Prior experience with Trial Master File (TMF) (oversight, review and/or reconciliation across clinical studies) is highly preferred.
  • Strong knowledge of applicable research and regulatory requirements, including International Council for Harmonization (ICH), Good Clinical Practice (GCP), and relevant local laws, regulations, and guidelines.
  • Working knowledge of technology applications relevant to records management environments.
  • Ability to identify and analyze problems, develop effective solutions, and make sound decisions.
  • Demonstrated ability to manage multiple tasks and projects within defined timelines while balancing competing priorities.
  • Strong attention to detail and ability to remain focused under pressure.
  • Excellent organizational, planning, and decision-making skills.
  • Strong written and verbal communication skills, including a solid command of the English language.
  • Ability to establish and maintain effective working relationships with internal and external clients.
  • Demonstrated ability to lead and guide others.

Benefits

Comp & perks
  • Health insurance
  • Retirement plans
  • Paid time off

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools
records managementTrial Master File (TMF)imagingscanningproject managementcompliance monitoringdata analysisproblem solvingquality assuranceregulatory requirements
Soft Skills
attention to detailorganizational skillsplanning skillsdecision-making skillscommunication skillsinterpersonal skillsleadershiptime managementability to manage multiple tasksability to work under pressure
Certifications
Bachelor’s degree in Records Managementcertification in clinical researchcertification in records management