TMF Quality Project Manager (Remote)

Job Overview

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.

Essential Functions

• Ensure project timelines are met and facilitate the orderly transfer imaging scanning retention and disposition of project-related and business records.
• Ensure all work is conducted in accordance with SOPs policies practices Good Clinical Practice (GCP) and applicable regulatory requirements and meets quality and timeline metrics.
• 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.
• Train team members on records management tasks policies and procedures.
• Serve as the primary point of contact for internal and external clients.
• 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.
• May function as team leader for records management projects.

Qualifications

• Bachelors 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.

This is a remote position open to candidates in the United States.

IQVIA is a leading global provider of clinical research services commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at

IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity national origin disability status as a protected veteran or any other status protected by applicable law. is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements misrepresentations or material omissions during the recruitment process will result in immediate disqualification of your application or termination of employment if discovered later in accordance with applicable law. We appreciate your honesty and professionalism.