TMF Quality Project Manager
About the job
- A bachelor's degree in Records Management or a related field, or an equivalent combination of education, training, and experience.
- At least four years of experience working in a technically related records management environment.
- Prior experience with Trial Master File oversight, review, and/or reconciliation across clinical studies.
- Strong knowledge of applicable research and regulatory requirements, including International Council for Harmonization requirements, Good Clinical Practice, 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.
- 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 English.
- Ability to establish and maintain effective working relationships with internal and external clients.
- Demonstrated ability to lead and guide others.
- 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 work follows Standard Operating Procedures, policies, practices, Good Clinical Practice, and applicable regulatory requirements, while meeting quality and timeline metrics.
- Ensure project timelines are met and facilitate the orderly transfer, imaging, scanning, retention, and disposition of project-related and business records.
- Coordinate retrieval of records requested by users and prepare closed studies for transfer to final destinations within agreed timelines.
- Monitor filing accuracy and compliance with company or customer file plans and Standard Operating Procedures.
- 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 Standard Operating Procedures.
- 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 transfer, recall, and disposition of records to commercial records storage centers.
- Oversee disposal of obsolete records and ensure efficient maintenance of records storage space, supplies, and equipment.
- Assist management with implementation of strategic goals, plans, cost proposals, and resource projections for records management projects.
- May lead records management project teams functionally, including awareness of scope of work, budget, and available resources.
About the company
IQVIA runs clinical trials for drug, biotech and medical device companies and sells them the health data, software and analytics they use to develop and market treatments. Its research arm designs studies, recruits trial sites and patients, and manages trials through to regulatory filing. Its commercial arm sells market data, consulting and software that pharma sales and marketing teams use to plan product launches. Clients pay through multi-year service contracts and data and software subscriptions. IQVIA was formed in 2016 when clinical research firm Quintiles merged with health data company IMS Health, and it is based in Durham, North Carolina.
Company Size
10,001+
Company Stage
IPO
Headquarters
Durham, North Carolina
Founded
1998
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Simplify's Take
What believers are saying
- Research work is booked years ahead: IQVIA held a $34.2 billion contracted trial backlog in June 2026.
- Big pharma is adopting its AI: 19 of the top 20 drugmakers began using IQVIA's AI agents by March 2026.
- Headcount keeps rising: IQVIA grew from about 88,000 employees in February 2025 to 93,000 by March 2026.
What critics are saying
- Debt limits room to invest: IQVIA carried $16 billion of debt against $1.9 billion of cash at June 30, 2026.
- Privacy rules bite: Italy fined IQVIA's Italian unit €7 million in September 2026 for unlawfully processing 1 million patients' records.
- Role cuts continue: IQVIA spent $105 million on restructuring, mostly severance, in 2025 and said in February 2026 cuts continue.
What makes IQVIA unique
- Its data doubles as industry research: the IQVIA Institute publishes Global R&D Trends and Global Medicine Use Trends reports.
- Its data reaches almost every medicine: IQVIA tracks about 90% of the world's pharmaceuticals, measured by 2024 sales.
- A Supreme Court ruling backs its data trade: predecessor IMS Health overturned Vermont's prescriber data limits in 2011.
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Benefits
Health Insurance
Dental Insurance
Life Insurance
Flexible Work Hours
Paid Vacation
Wellness Program
401(k) Retirement Plan
Growth & Insights and Company News
6 month growth
-1%1 year growth
0%2 year growth
0%IQVIA launches IQVIA Explorer to help life sciences companies make better commercial decisions. Key Takeaway: IQVIA has launched IQVIA Explorer at TechIQ 2026, aimed at assisting life sciences companies in making informed commercial decisions. This new tool enables users to convert complex analytics projects into a continuous commercial intelligence resource. It allows for the application of external indicators to address business questions effectively. Market sentiment analysis. Positive factors. * Launch of IQVIA Explorer enhances decision-making for life sciences companies. * Provides an always-on commercial intelligence capability. * Transforms complex analytics into user-friendly insights. RESEARCH TRIANGLE PARK, N.C.-(BUSINESS WIRE)-IQVIA (NYSE:IQV), a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries, today at TechIQ 2026 introduced IQVIA Explorer(TM) to help customers make better-informed commercial decisions. IQVIA Explorer turns complex, one-time analytics projects into an always-on commercial intelligence capability. Users can apply external indicators and ask business questio Frequently asked questions. What is IQVIA Explorer? IQVIA Explorer is a new tool designed to help life sciences companies make informed commercial decisions. When was IQVIA Explorer launched? IQVIA Explorer was launched at TechIQ 2026. How does IQVIA Explorer assist users? It transforms complex analytics projects into an always-on commercial intelligence capability. What industries does IQVIA serve? IQVIA provides services to the life sciences and healthcare industries.
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IQVIA launches IQVIA Life Science Models to help life sciences companies predict clinical trial outcomes. 10/07/2026 RESEARCH TRIANGLE PARK, N.C.-(BUSINESS WIRE)- IQVIA (NYSE:IQV), a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries, today at TechIQ 2026 introduced IQVIA Life Science Models(TM) to help predict clinical trial outcomes. IQVIA Life Science Models are a suite of purpose-built models for life sciences, combining IQVIA's proprietary expert content, deep domain knowledge and established regulatory, compliance and privacy frameworks. Built using technologies including NVIDIA Nemotron(TM) and supported by Amazon Web Services (AWS) infrastructure, the models connect molecular and treatment information with patient journeys and clinical outcomes to enable predictive applications across clinical development. * Clinical study simulation and protocol optimization, including endpoint selection, patient eligibility criteria, dose selection and sample size planning, helping teams identify risks before trials begin. In initial evaluation across 50 trials and 270 endpoints, 85% of predictions were on target or clinically close. * Digital twins and synthetic controls that support more efficient study designs. * Leverage clinical study predictions to inform better real-world planning and access. In clinical development, Life Science Models extend IQVIA's Predictive Clinical Development approach, enabling sponsors to simulate studies and test key assumptions before execution, helping optimize study design and identify potential risks earlier. About IQVIA IQVIA (NYSE:IQV) is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. IQVIA's portfolio of solutions are powered by IQVIA Connected Intelligence(TM) to deliver actionable insights and services built on high-quality health data, Healthcare-grade AI(R), advanced analytics, the latest technologies and extensive domain expertise. IQVIA is committed to using AI responsibly, with AI-powered capabilities built on best-in-class approaches to privacy, regulatory compliance and patient safety, and delivering AI to the high standards of trust, scalability and precision demanded by the industry. With approximately 94,000 employees in over 100 countries, including experts in healthcare, life sciences, data science, technology and operational excellence, IQVIA is dedicated to accelerating the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. IQVIA is a global leader in protecting individual patient privacy. The company uses a wide variety of privacy-enhancing technologies and safeguards to protect individual privacy while generating and analyzing information on a scale that helps healthcare stakeholders identify disease patterns and correlate with the precise treatment path and therapy needed for better outcomes. IQVIA's insights and execution capabilities help biotech, medical device and pharmaceutical companies, medical researchers, government agencies, payers and other healthcare stakeholders tap into a deeper understanding of diseases, human behaviors and scientific advances, in an effort to advance their path toward cures. To learn more, visit www.iqvia.com. Kerri Joseph, IQVIA Investor Relations ([email protected]) +1.973.541.3558 Multimedia Files: Company's logo
IQVIA fined $7.8 million for failing to properly anonymize health data. By Bill Toulas Monday, October 5, 2026 BleepingComputer Italy's data regulator fined IQVIA $7.8 million for failing to properly anonymize the medical records of one million patients. This enforcement highlights a critical flaw in health-tech security: "pseudonymized" data often remains identifiable. For the industry, it serves as a stark warning that GDPR compliance require BleepingComputer
The Italian Italy's Data Protection Authority fines IQVIA €7 million over data protection breach. The following is a machine translation of a press release by Italy's privacy guarantor: Healthcare data: The Privacy Guarantor fines IQVIA 7 million euros. The data of one million patients of 800 family doctors are not anonymous. The Italian Data Protection Authority has fined IQVIA Solutions Italy Srl €7 million. The company, part of a... Introduction to Malware Binary Triage (IMBT) Course Looking to level up your skills? Get 10% off using coupon code: MWNEWS10 for any flavor. Enroll Now and Save 10%: Coupon Code MWNEWS10 Note: Affiliate link - your enrollment helps support this platform at no extra cost to you. New & unread topics.