TMF Quality Project Manager

IQVIA

Liaison between Records Management and user departments regarding Trial Master Files at IQVIA. Ensuring compliance with SOPs and project timelines in a clinical research environment.

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