Trial Master File Quality Project Manager

Title: TMF Quality Project Manager (Remote)

Location: New York, United States of America

Full time | Home-based | R1537082

Job Description:

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

• 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.

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. 

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. 

IQVIA 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.

The potential base pay range for this role, when annualized, is $47,400.00 - $118,600.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.